Device product
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.
Z-1623-2015
Product summary
- Firm
- GE Healthcare
- Event
- Event 71167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 USA
- Official record key
device-enforcement:Z-1623-2015
Official wording
Reason: 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
Code information: Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT 00000344962CN6 INSIGHTPCT1356
Distribution pattern: Distributed to the states of MN, FL & TX.
Derived failure modes
-
Unknown
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