Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 21, 2024
OEC Elite REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Reason: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Root cause: Process control
Recalling firm: GE OEC Medical Systems, IncType: Image-Intensified Fluoroscopic X-Ray System, MobileDistribution: U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United KingdomRecall #Z-0704-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 21, 2024
OEC 9900 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Reason: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Root cause: Process control
Recalling firm: GE OEC Medical Systems, IncType: Image-Intensified Fluoroscopic X-Ray System, MobileDistribution: U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United KingdomRecall #Z-0705-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 21, 2024
OEC 9800 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Reason: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Root cause: Process control
Recalling firm: GE OEC Medical Systems, IncType: Image-Intensified Fluoroscopic X-Ray System, MobileDistribution: U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United KingdomRecall #Z-0706-2025
Open, ClassifiedPosted Dec 17, 2024·Initiated Nov 25, 2024
Eclipse PRO REF 98700
The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Reason: Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
Root cause: Process control
Recalling firm: Spacelabs Healthcare, Ltd.Type: Electrocardiograph, Ambulatory (Without Analysis)Distribution: U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI.
O.U.S.:
Argentina
Denmark
Kuwait
Serbia
Australia
Dominican Republic
Lebanon
Singapore
Austria
Ecuador
Lithuania
Spain
Belgium
El Salvador
Martinique
Sweden
Benin
France
Mexico
Switzerland
Bolivia
Germany
Netherlands
Taiwan
Brazil
Greece
Oman
Trinidad and Tobago
Brunei Darussalam
Guatemala
Panama
Turkey
Canada
Honduras
Peru
United Arab Emirates
Chile
Hong Kong
Poland
United Kingdom
China
Iceland
Portugal
Columbia
India
Venezuela
Congo
Ireland
Qatar
Viet Nam
Costa Rica
Israel
Republic of Macedonia
Croatia
Italy
Roumanie
Czech Republic
Korea, Republic of
Saudi ArabiaRecall #Z-0684-2025
Open, ClassifiedPosted Dec 17, 2024·Initiated Nov 25, 2024
Eclipse Mini REF 98900
The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
Reason: Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
Root cause: Process control
Recalling firm: Spacelabs Healthcare, Ltd.Type: Electrocardiograph, Ambulatory (Without Analysis)Distribution: U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI.
O.U.S.:
Argentina
Denmark
Kuwait
Serbia
Australia
Dominican Republic
Lebanon
Singapore
Austria
Ecuador
Lithuania
Spain
Belgium
El Salvador
Martinique
Sweden
Benin
France
Mexico
Switzerland
Bolivia
Germany
Netherlands
Taiwan
Brazil
Greece
Oman
Trinidad and Tobago
Brunei Darussalam
Guatemala
Panama
Turkey
Canada
Honduras
Peru
United Arab Emirates
Chile
Hong Kong
Poland
United Kingdom
China
Iceland
Portugal
Columbia
India
Venezuela
Congo
Ireland
Qatar
Viet Nam
Costa Rica
Israel
Republic of Macedonia
Croatia
Italy
Roumanie
Czech Republic
Korea, Republic of
Saudi ArabiaRecall #Z-0685-2025
Open, ClassifiedPosted Dec 17, 2024·Initiated Nov 20, 2024
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Reason: The following four issues are included:
1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network.
2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the Access Point may not transition through the desired state to all for clean reconnection of the client radio link.
3. Potential to experience higher than expected data dropouts, device disassociations/reassociations for their wireless clients, and frequent "Loss of AP" alerts.
4. Potential for the Smart-hopping Access Point is affected by a software issue where the Access Point will resent after 82.85 days when the frame counter reaches its limit. This causes the latest synchronization check to fail and potential for loss of patient data.
Root cause: Under Investigation by firm
Recalling firm: Philips North America LlcType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Nationwide distributionRecall #Z-0686-2025 Open, ClassifiedPosted Dec 16, 2024·Initiated Nov 14, 2024
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Reason: Potential for the outer stainless-steel tube to break or detach.
Root cause: Device Design
Recalling firm: Kirwan Surgical Products, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.Recall #Z-0654-2025
Open, ClassifiedPosted Dec 16, 2024·Initiated Nov 14, 2024
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Reason: Potential for the outer stainless-steel tube to break or detach.
Root cause: Device Design
Recalling firm: Kirwan Surgical Products, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.Recall #Z-0655-2025
Open, ClassifiedPosted Dec 16, 2024·Initiated Nov 14, 2024
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Reason: Potential for the outer stainless-steel tube to break or detach.
Root cause: Device Design
Recalling firm: Kirwan Surgical Products, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.Recall #Z-0656-2025
Open, ClassifiedPosted Dec 16, 2024·Initiated Nov 14, 2024
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Component: No
Reason: Potential for the outer stainless-steel tube to break or detach.
Root cause: Device Design
Recalling firm: Kirwan Surgical Products, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.Recall #Z-0657-2025
Open, ClassifiedPosted Dec 16, 2024·Initiated Nov 14, 2024
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Reason: Potential for the outer stainless-steel tube to break or detach.
Root cause: Device Design
Recalling firm: Kirwan Surgical Products, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.Recall #Z-0658-2025
Open, ClassifiedPosted Dec 16, 2024·Initiated Nov 14, 2024
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Reason: Potential for the outer stainless-steel tube to break or detach.
Root cause: Device Design
Recalling firm: Kirwan Surgical Products, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.Recall #Z-0659-2025
Open, ClassifiedPosted Dec 16, 2024·Initiated Nov 14, 2024
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Reason: Potential for the outer stainless-steel tube to break or detach.
Root cause: Device Design
Recalling firm: Kirwan Surgical Products, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.Recall #Z-0660-2025
Open, ClassifiedPosted Dec 16, 2024·Initiated Nov 25, 2024
Turbo Elite Laser Atherectomy Catheter
Model Number / UDI-DI code / Product Description
414-151 / 989930000531 / 1.4 mm OTW
417-152 / 989930000551 / 1.7 mm OTW
420-006 / 989930000571 / 2.0 mm OTW
423-001 / 989930000591 / 2.3 mm OTW
425-011 / 989930000601 / 2.5 mm OTW
423-135-01 / 989930004171 / 2.3 mm OTW
423-135-02 / 989930004181 / 2.3 mm OTW
425-135-01 / 989930004201 / 2.5 mm OTW
425-135-02 / 989930004211 / 2.5 mm OTW
The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
Reason: Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Root cause: Device Design
Recalling firm: Spectranetics CorporationType: Catheter, Peripheral, AtherectomyDistribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD TN, TX, UT, VA, WA, WI, and WV.
O.U.S.: Australia, Belgium, Brazil, China, Croatia, Cyprus, Czech Republic, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Poland, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.Recall #Z-0680-2025
Open, ClassifiedPosted Dec 13, 2024·Initiated Oct 25, 2024
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Reason: Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.
Root cause: Device Design
Recalling firm: Noah MedicalType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NCRecall #Z-0679-2025
Open, ClassifiedPosted Dec 12, 2024·Initiated May 31, 2023
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Reason: Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
Root cause: Software design
Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: Worldwide and US Nationwide Distribution: NJ, PR, CARecall #Z-0664-2025
Open, ClassifiedPosted Dec 12, 2024·Initiated Nov 28, 2023
MICRO-X Rover Mobile X-ray System, # MXU-RV35;
MICRO-X Rover Mobile X-ray System, # MXU-RV71
Reason: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Root cause: Device Design
Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: US Nationwide Distribution: NJ, CA, PRRecall #Z-0665-2025
Open, ClassifiedPosted Dec 12, 2024·Initiated Oct 23, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Reason: During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
Root cause: Device Design
Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: US Nationwide Distribution: TX, CA, OH, ID, WA, AZRecall #Z-0666-2025
Open, ClassifiedPosted Dec 12, 2024·Initiated Nov 11, 2024
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following:
1. Allura Xper FD10, Model Number: 722010.
2. Allura Xper FD10/10, Model Number: 722011.
3. Allura Xper FD20, Model Number: 722012.
4. Allura Xper FD20 Biplane, Model Number: 722013.
5. Allura Xper FD10 OR Table, Model Number: 722022.
6. Allura Xper FD20 OR Table, Model Number: 722023.
7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
Reason: Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
Root cause: Equipment maintenance
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen.Recall #Z-0676-2025
Open, ClassifiedPosted Dec 12, 2024·Initiated Nov 7, 2024
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Reason: Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
Root cause: Process control
Recalling firm: Diasorin Inc.Type: Calprotectin, FecalDistribution: WorldwideRecall #Z-0677-2025