Device product
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Z-1407-2015
Product summary
- Firm
- GE Healthcare
- Event
- Event 70924
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units in US
- Official record key
device-enforcement:Z-1407-2015
Official wording
Reason: An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Code information: OptimaXR220amx PN 5555000-5, PN5555000-6
Distribution pattern: US Distribution to the states of: AZ, FL, GA, MO and WI.
Derived failure modes
-
Unknown
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.