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
The SMV BodyTrack system is used in Nuclear Medicine for diagnostic imaging. Healthcare providers typically use this device to assess various medical conditions through advanced imaging techniques.
Why This Is Dangerous
The risk arises from inadequate support for the detector during transport, which can lead to a fall. Such an incident could result in significant injury due to the heavy weight of the detector.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers, particularly healthcare providers, face potential risks and must act quickly to avoid using a hazardous device.
Practical Guidance
How to identify if yours is affected
- Verify the model number and serial number against the list of affected products.
- Check for communications from GE HealthCare regarding this recall.
- Consult with your healthcare provider about the status of your device.
Where to find product info
The serial numbers can typically be found on the device's identification label or in the device's documentation.
What timeline to expect
Expect a refund or replacement process to take 4-6 weeks once initiated.
If the manufacturer is unresponsive
- Document all communication attempts with GE HealthCare.
- Contact relevant regulatory bodies for assistance if there is no response.
How to prevent similar issues
- Always check for product recalls prior to purchase.
- Ensure proper installation and support for medical devices during transport.
Documentation advice
Keep copies of all communications regarding the recall, including emails and phone call notes.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall affects 12 Nuclear Medicine systems past their End of Guaranteed Service. These systems have not been manufactured for several years and are distributed in the U.S., Canada, and several other countries.
Key Facts
- Potential detector fall risk
- No injuries reported
- Affected systems past End of Guaranteed Service
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.