GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls MAXXUS
- Recalling company
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product
- MAXXUS, System, Tomography, Computed, Emission
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 10, 2025
- Reported
- Jan 21, 2026
- Distribution
- US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- Status
- Ongoing
- Quantity
- 38 units
- Lot / codes
- UDI/DI Not applicable: All serial numbers in distribution
- Company location
- Tirat Carmel
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1047-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1047-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.