Device product
GE Optional Laser Centering Device X-ray generator.
Z-2320-2015
Product summary
- Event
- Event 69849
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-2320-2015
Official wording
Reason: GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.
Code information: Model No. 025.03.00A
Distribution pattern: US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
Derived failure modes
-
Unknown
GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.