GE HealthCare SMV DSX nuclear medicine systems recalled for detector fall hazard
What this means
GE HealthCare identified that certain older SMV DSX nuclear medicine systems may not have been properly supported during transport or relocation. This could damage the detector mounting mechanisms and potentially cause the detector to fall, creating a serious safety risk. No injuries have been reported so far.
- If you operate a GE HealthCare SMV DSX system, contact GE HealthCare immediately for inspection and guidance
- Do not transport or relocate the system without confirming proper detector support with GE HealthCare
- Ensure the detector mounting mechanisms are intact before using the system
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-1044-2026Want us to check the next one for you?
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