SMV DSX New Line recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)
Medical deviceClass IIOngoing
Summary: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling SMV DSX New Line, 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.
What is being recalled
SMV DSX New Line, System, Tomography, Computed, Emission
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
How to tell if yours is affected
UDI/DI Not applicable: All serial numbers in distribution
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1044-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 10, 2025 |
| Reported | January 21, 2026 |
| Company | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Company location | Tirat Carmel, Israel |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 units |
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