Device product
GE Discovery MR950 MRI system
Z-1395-2015
Product summary
- Firm
- GE Healthcare
- Event
- Event 70701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units (2 in US)
- Official record key
device-enforcement:Z-1395-2015
Official wording
Reason: The alignment lasers are missing the labels required by radiation safety regulations.
Code information: Model Number - Discovery MR950
Distribution pattern: US Distribution to the state of CA., and Internationally to Italy and Japan.
Derived failure modes
-
Unknown
The alignment lasers are missing the labels required by radiation safety regulations.