Device product
IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
Z-1266-2018
Product summary
- Event
- Event 79488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-1266-2018
Official wording
Reason: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
Code information: (a) 114093-000, Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10005612, 10004372, 10002841, 10002255, 10005613 (b) 114093-600, Serial Numbers: 10007411, 10002996, 10004515
Distribution pattern: US, Canada, China, Australia, Sweden, Germany
Derived failure modes
-
Unknown
The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.