FDA-Device2015-05-27Class II
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.
GE Healthcare
Hazard
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
Sold states
Distributed to the states of MN, FL & TX.
Affected count
4 USA
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1623-2015Don't want to check this manually?
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