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, allowing healthcare providers to visualize organ function and structure. These systems are critical in various medical settings, particularly in oncology and cardiology.
Why This Is Dangerous
The hazard arises from improper support during transport, which can lead to excessive stress on the detector mounting mechanisms. This could result in the detector falling, posing a serious injury risk to patients and healthcare staff.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate action from healthcare providers to prevent potential injuries, impacting patient care and safety protocols.
Practical Guidance
How to identify if yours is affected
- Verify the model and serial number against the affected product list provided by GE HealthCare.
- Check the manufacturing date to confirm if it falls within the impacted range.
- Contact your healthcare facility's biomedical engineering department for assistance.
Where to find product info
The model and serial numbers can usually be found on the back or side of the device, or in the user manual.
What timeline to expect
Expect a response time of 4-6 weeks for follow-up instructions or refund processing.
If the manufacturer is unresponsive
- Document your attempts to contact the manufacturer.
- Reach out to the FDA for further guidance on the recall process.
- Consider contacting a legal professional if the situation remains unresolved.
How to prevent similar issues
- Ensure that any medical equipment is properly supported during transport.
- Regularly review the manufacturer's service updates and recalls for any relevant information.
- Consult with biomedical engineers on best practices for equipment handling.
Documentation advice
Keep a record of all correspondence related to the recall, including dates, times, and the names of individuals you spoke with.
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Product Details
The recall affects 38 units of Nuclear Medicine systems from GE HealthCare. These systems are past their End of Guaranteed Service and have been distributed in the US, Canada, Brazil, and several European countries.
Key Facts
- Potential for life-threatening injuries
- Class II recall due to high hazard level
- No reported incidents of falls or injuries
- Contact manufacturer for further instructions
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Safety Guide
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