Device product
IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
Z-1263-2018
Product summary
- Event
- Event 79488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-1263-2018
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) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10003241, 10002607, 10002848, 10005651, 10007348, 10007424, 10004250, 10004439, 10004576, 10006438, 100030007, 10006887, 10006886 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003065
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.