Reported May 27, 2015 · Terminated
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner…
GE Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
- Lot codes and dates
- Mfg Lot or Serial # System ID
00000331100CN8904223CT00000345975CN7409838LS1600000337343CN8512OCCT00000344962CN6INSIGHTPCT1356
- Mfg Lot or Serial # System ID
- Amount recalled
- 4 USA
Where it was sold
Why it was recalled
GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the component becomes loose on the CT gantry during operation, it could result in serious bodily injury if the component were expelled. There were no incidents or injuries reported as a res
This product could cause temporary or reversible health problems — stop using it.
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