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
- Unknown
- 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
- Unknown
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 and treatment in healthcare settings. They help in detecting and monitoring various medical conditions through imaging techniques.
Why This Is Dangerous
The risk arises from inadequate support for the detectors during transportation or relocation, which can compromise their mounting and potentially lead to a fall.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may necessitate immediate cessation of use for affected facilities, impacting patient care and leading to possible delays in medical imaging.
Practical Guidance
How to identify if yours is affected
- Locate the serial number on your Nuclear Medicine system.
- Check the recall notification from GE HealthCare for affected serial numbers.
- Contact GE Medical Systems Israel if you are unsure about your system's status.
Where to find product info
Serial numbers can typically be found on the back or bottom of the device. Refer to the user manual for specific locations.
What timeline to expect
Expect a refund or replacement to be processed within 4-8 weeks after the recall notification.
If the manufacturer is unresponsive
- Document all communications with the company.
- Consider escalating the matter to the FDA if there is no response within a reasonable timeframe.
- Reach out to local consumer protection agencies for assistance.
How to prevent similar issues
- Ensure proper support during the transportation of medical devices.
- Regularly check for recalls on medical devices from manufacturers.
- Keep updated with the manufacturer's service and support policies.
Documentation advice
Keep copies of all receipts, notification letters, and any correspondence related to the recall for your records.
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Product Details
The recall affects three units of the Nuclear Medicine systems from GE HealthCare. These systems have not been manufactured for several years and were distributed across the US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain, Chile, Germany, Iran, and Greece.
Key Facts
- Recall date: December 10, 2025
- Reported date: January 21, 2026
- Quantity recalled: 3 units
- No reported injuries or falls
- Class II recall classification
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Safety Guide
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