Device product
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Z-2244-2012
Product summary
- Event
- Event 62571
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-2244-2012
Official wording
Reason: A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
Code information: Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.
Distribution pattern: Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
Derived failure modes
-
Unknown
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.