Quick Facts at a Glance
- Recall Date
- December 10, 2025
- Hazard Level
- HIGH
- Brand
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product type
- Nuclear Medicine System
- Model numbers
- UDI/DI Not applicable: All serial numbers in distribution
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 10, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING or your healthcare provider for instructions. Notification method: Telephone
About This Product
Nuclear Medicine systems are used for diagnostic imaging in healthcare settings. They provide important information about the function of organs and tissues.
Why This Is Dangerous
The hazard arises from inadequate support during transportation, which can stress the mounting mechanisms and risk a fall of the detector.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a serious safety risk, as a falling detector could lead to life-threatening injuries.
Practical Guidance
How to identify if yours is affected
- Verify the serial numbers against the list of affected products provided by GE Healthcare.
- Inspect the device for any signs of damage or inadequate support.
- Contact your healthcare provider for guidance on your specific system.
Where to find product info
Serial numbers can typically be found on the device's identification plate or user manual.
What timeline to expect
Expect a resolution timeline of approximately 6-8 weeks for refund or replacement processing.
If the manufacturer is unresponsive
- Document all communications with GE Healthcare.
- Follow up with a secondary contact if no response is received.
How to prevent similar issues
- Ensure that any medical devices are properly supported during transport.
- Regularly check for updates on device safety recalls from manufacturers.
Documentation advice
Keep a record of all correspondence, including emails and phone calls, related to the recall.
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Product Details
The recall involves seven units of the Nuclear Medicine systems from GE Healthcare. These systems have not been manufactured for several years and are distributed in the U.S., Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain, Chile, Germany, Iran, and Greece.
Key Facts
- Recall date: December 10, 2025
- Quantity recalled: 7 units
- No reported injuries
- Affected regions include multiple countries
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Safety Guide
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