FDA recall, , Moderate risk
GE Medical Systems Israel Emission Computed Tomography Systems
Certain Nuclear Medicine systems could have been transported or relocated without adequate detector support.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems Israel, Functional Imaging, located in Tirat Carmel, Israel, began a recall on December 10, 2025, for certain Nuclear Medicine systems that 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.
The affected products include SMV Dsi, SMV BodyTrack, Maxxus System, and SMV DSX New Line. The recall was added to the FDA's Enforcement Report on January 9, 2026, and distributed in the US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain, Chile, Germany, Iran, and Greece.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
SMV DSI, System, Tomography, Computed, Emission
- Lot code
- UDI/DI Not applicable: All serial numbers in distribution
SMV BodyTrack, System, Tomography, Computed, Emission
- Lot code
- UDI/DI Not applicable: All serial numbers in distribution
Maxxus, System, Tomography, Computed, Emission
- Lot code
- UDI/DI Not applicable: All serial numbers in distribution
SMV DSX New Line, System, Tomography, Computed, Emission
- Lot code
- UDI/DI Not applicable: All serial numbers in distribution
Recall details
- Company began the recall
- Sold in
US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- Company
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGTirat Carmel, Israel
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98133
- Recall numbers
- Z-1044-2026 to Z-1047-2026
All recalls from GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
