GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: SMV DSX New Line, System, Tomography, Computed, Emission
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product
- SMV DSX New Line, System, Tomography, Computed, Emission
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- Recall initiated
- 2025-12-10
- Code info
- UDI/DI Not applicable: All serial numbers in distribution
- Product quantity
- 7 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tirat Carmel
- Country
- Israel
- Event id
- 98133
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