Device product
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Z-0985-2015
Product summary
- Firm
- GE Healthcare
- Event
- Event 70074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 (7 US, 6 OUS)
- Official record key
device-enforcement:Z-0985-2015
Official wording
Reason: Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
Code information: Mfg Lot or Serial # System ID 00000437461CN7 519646REVO1 00000437837CN8 M2322254 00000438342CN8 828210096 00000437028CN4 REV001 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000439068CN8 AE1477CT01 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3
Distribution pattern: US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.
Derived failure modes
-
Unknown
Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.