United StatesSMV DSX New Line, SMV DSI, SMV BodyTrack and MAXXUS nuclear medicine (computed emission tomography) systems that are past their End of Guaranteed Service — identified as all serial numbers in distribution — are affected. GE HealthCare says these systems could have been transported or relocated without adequate detector support, which can overstress detector mounting mechanisms and potentially lead to a detector fall and life‑threatening injury; no detector falls or injuries have been reported.
What's being recalled
SMV DSX New Line, System, Tomography, Computed, Emission
SMV DSI, System, Tomography, Computed, Emission
SMV BodyTrack, System, Tomography, Computed, Emission
MAXXUS, System, Tomography, Computed, Emission
Recalling firm: Ge Medical Systems Israel, Functional Imaging, Tirat Carmel, Israel.
How to identify it
UDI/DI Not applicable: All serial numbers in distribution
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada