Device product
Biograph mCT Flow Edge-4R, Model Number 10528955
Z-2335-2015
Product summary
- Event
- Event 71712
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2335-2015
Official wording
Reason: Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
Code information: SERIAL NUMBERS: 11002, 11005, 1008
Distribution pattern: Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
Derived failure modes
-
Unknown
Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.