Open, ClassifiedPosted Feb 5, 2025·Initiated Jan 15, 2025
IntelliVue Patient Monitor MX450. Model Number: 866062
Reason: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Root cause: Software design
Recalling firm: Philips North America LlcType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.Recall #Z-1108-2025 Open, ClassifiedPosted Feb 5, 2025·Initiated Jan 15, 2025
IntelliVue Patient Monitor MX500. Model Number: 866064
Reason: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Root cause: Software design
Recalling firm: Philips North America LlcType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.Recall #Z-1109-2025 Open, ClassifiedPosted Feb 5, 2025·Initiated Jan 15, 2025
IntelliVue Patient Monitor MX550. Model Number: 866066
Reason: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Root cause: Software design
Recalling firm: Philips North America LlcType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.Recall #Z-1110-2025 Open, ClassifiedPosted Feb 5, 2025·Initiated Dec 6, 2024
Temporary Titanium Abutments
Reason: Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
Root cause: Component design/selection
Recalling firm: DDS LabType: Abutment, Implant, Dental, EndosseousDistribution: US Nationwide distribution including in the states of FL, TN, TX, MA, NH, CT, ME, WA, IN, CA, PA, NV, MO, IL, AK, MN, VT, OH, MI, VA, WI, AL, AZ, KY, MT, OK, CO, LA, GA, NY, WV, NC, NJ, MD, OR, DE, SC, ID, KS, IA, AR, NM, HI, DC, MS, NE, RI, UT.Recall #Z-1111-2025
Open, ClassifiedPosted Feb 5, 2025·Initiated Jan 2, 2025
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Reason: Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
Root cause: Under Investigation by firm
Recalling firm: Beckman Coulter Inc.Type: Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu AdmissionDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark,
France, Germany, Greece, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Slovakia, South Africa, Spain, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam.Recall #Z-1112-2025
Open, ClassifiedPosted Feb 5, 2025·Initiated Jan 6, 2025
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.
Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
Reason: Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
Root cause: Software design
Recalling firm: Sysmex America, Inc.Type: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisDistribution: US Nationwide.Recall #Z-1113-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 10, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005.
Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Reason: Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies:
1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more.
2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Root cause: Software Design Change
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.Recall #Z-1019-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Dec 26, 2024
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Reason: There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
Root cause: Nonconforming Material/Component
Recalling firm: ROi CPS LLCType: Labor And Delivery KitDistribution: Distribution was made to MO. There was no government/military/foreign distribution.Recall #Z-1047-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Dec 23, 2024
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Reason: Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
Root cause: Under Investigation by firm
Recalling firm: Oxoid LimitedType: Susceptibility Test Discs, AntimicrobialDistribution: US: VA, CA, NE, MA, FL, CA, MA, NH, WA
OUS: Austria, Australia, Brazil, Canada, China, Costa Rica, Germany, Spain, France, United Kingdom, Ghana, Hong Kong, South Korea, Netherlands, Peru, Philippines, Poland, IndonesiaRecall #Z-1075-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Allura CV20
System Code: 722031
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1076-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Allura Xper FD10
Catalog
(1) 722003
(2) 722010
(3)722026
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1077-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
AlluraXper FD10/10
System Code:
(1) 722005
(2) 722011
(3) 722027
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1078-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Allura Xper FD10C
System Code:
(1) 722001
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1079-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
AlluraXper FD20
System Code:
(1) 722006
(2) 722012
(3) 722028
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1080-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
AlluraXper FD20 Biplane
System Code:
(1) 722008
(2) 722013
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1081-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
AlluraXper FD20 Biplane OR Table
System Code:
(1) 722020
(2) 722025
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1082-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
AlluraXper FD20 OR Table
System Code:
(1) 722023
(2) 722035
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1083-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
AlluraXperFD20/10
System Code:
(1) 722029
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1084-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
Allura Xper FD20/20
System Code:
(1) 722038
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1085-2025
Open, ClassifiedPosted Feb 4, 2025·Initiated Jan 13, 2025
AlluraXperFD20/15
System Code:
(1) 722058
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,
Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,
Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,
Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,
Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,
Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,
Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,
India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,
Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,
Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,
Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman,
Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,
Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal
Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,
Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,
Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-1086-2025