Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 17, 2025
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Reason: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Root cause: Software change control
Recalling firm: Philips Medical Systems (Cleveland) IncType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.Recall #Z-2239-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Apr 7, 2025
Molding Equipment. WCM series. Model WCM-330GL-i
Reason: Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic
product regulations in that they did not bear a required label.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Apic Yamada AmericaType: Laser Marker Or Engraver, Industrial Or CommercialDistribution: USRecall #Z-2150-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jun 16, 2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Root cause: Process control
Recalling firm: Draeger, Inc.Type: Filter, Bacterial, Breathing-CircuitDistribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.Recall #Z-2158-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jun 16, 2025
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Root cause: Process control
Recalling firm: Draeger, Inc.Type: Filter, Bacterial, Breathing-CircuitDistribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.Recall #Z-2159-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jun 16, 2025
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Root cause: Process control
Recalling firm: Draeger, Inc.Type: Filter, Bacterial, Breathing-CircuitDistribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.Recall #Z-2160-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jun 16, 2025
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Root cause: Process control
Recalling firm: Draeger, Inc.Type: Filter, Bacterial, Breathing-CircuitDistribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.Recall #Z-2161-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jun 18, 2025
Brand Name: Osteotec
Product Name: Osteotec Silicone Finger Implant
Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)
Software Version: N/A
Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which
is placed, during arthroplasty, in the proximal and distal intramedullary canals of either
metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the
bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes
to meet various anatomical variations and is supplied sterile.
Component: N/A
Reason: There is the potential that the silicone implant may contain foreign material
Root cause: Process change control
Recalling firm: Osteotec LimitedType: Prosthesis, Finger, Constrained, PolymerDistribution: US Nationwide distribution in the state of CA.Recall #Z-2222-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jul 11, 2025
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes.
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Culture Media, Non-Selective And DifferentialDistribution: US Nationwide distribution.Recall #Z-2223-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jul 11, 2025
Strep Selective II Agar, Product Number R01859
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes.
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Culture Media, Selective And DifferentialDistribution: US Nationwide distribution.Recall #Z-2224-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jul 11, 2025
Blood/EMB, Levine 100/PK, Product Number R02041
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes.
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Culture Media, Selective And DifferentialDistribution: US Nationwide distribution.Recall #Z-2225-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jul 11, 2025
Blood/MacConkey Biplate 100/PK, Product Number R02049
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes.
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Culture Media, Selective And DifferentialDistribution: US Nationwide distribution.Recall #Z-2226-2025
Open, ClassifiedPosted Jul 31, 2025·Initiated Jun 26, 2025
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Reason: Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics IncType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.Recall #Z-2230-2025 Open, ClassifiedPosted Jul 30, 2025·Initiated Jun 26, 2025
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Reason: Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
Root cause: Process control
Recalling firm: Hamilton Medical AGType: Set, Tubing And Support, Ventilator (W Harness)Distribution: US Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC, NJ, UT, TX, GA, SC, VA, IN, SD, MO, OR, TN, MA, AZ, NM.Recall #Z-2167-2025
Open, ClassifiedPosted Jul 30, 2025·Initiated Jun 16, 2025
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL
Model no. EMZE010301
Reason: SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cap, Device DisinfectantDistribution: Worldwide distribution - US Nationwide and the countries of Canada and Panama.Recall #Z-2199-2025
Open, ClassifiedPosted Jul 30, 2025·Initiated Jun 30, 2025
Achieva 3.0T;
Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Root cause: Device Design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.Recall #Z-2200-2025
Open, ClassifiedPosted Jul 30, 2025·Initiated Jun 30, 2025
Achieva XR;
Model Numbers (REF): (1) 781153, (2) 781253;
Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Root cause: Device Design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.Recall #Z-2201-2025
Open, ClassifiedPosted Jul 30, 2025·Initiated Jun 30, 2025
Evolution Upgrade 1.5T
Model Numbers (REF): (1) 782116, (2) 782148;
Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Root cause: Device Design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.Recall #Z-2202-2025
Open, ClassifiedPosted Jul 30, 2025·Initiated Jun 30, 2025
Evolution Upgrade 3.0T
Model Numbers (REF): (1) 782117, (2) 782143;
Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Root cause: Device Design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.Recall #Z-2203-2025
Open, ClassifiedPosted Jul 30, 2025·Initiated Jun 30, 2025
Ingenia 1.5T
Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Root cause: Device Design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.Recall #Z-2204-2025
Open, ClassifiedPosted Jul 30, 2025·Initiated Jun 30, 2025
Ingenia 1.5T S
Model Number (REF): 781347;
Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Root cause: Device Design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.Recall #Z-2205-2025