Device product
IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
Z-1265-2018
Product summary
- Event
- Event 79488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-1265-2018
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) 108000-000, Serial Numbers: 10000239, 10000983, 10000233 (b) 108000-600, Serial Numbers: 10001306 (c) 109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d) 109682-600, Serial Numbers: 10001119, 10003623, 05-002, 10003634, 10001188, 10003638, 10001192
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.