GE HealthCare SMV DSI nuclear medicine system recalled for detector fall hazard
What this means
GE HealthCare discovered that certain older SMV DSI nuclear medicine systems may have been moved or transported without proper detector support. This can stress the detector mounting and potentially cause the detector to fall, which could injure someone. No falls or injuries have occurred yet.
- If your facility owns an SMV DSI system past its End of Guaranteed Service, contact GE HealthCare immediately to verify if your unit is affected
- Do not transport or relocate the system without first confirming proper detector support with GE HealthCare
- Inspect detector mounting mechanisms for any signs of damage or stress
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1045-2026Want us to check the next one for you?
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