Device product
ROSA Surgical Device 2.5.8
Z-0178-2018
Product summary
- Event
- Event 77672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 units (4 US and 18 OUS)
- Official record key
device-enforcement:Z-0178-2018
Official wording
Reason: Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Code information: Serial No. RO10011, RO10014, RO13023 and RO13027
Distribution pattern: AR, OH, MI, and TX
Derived failure modes
-
Unknown
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.