Device product
IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
Z-1264-2018
Product summary
- Event
- Event 79488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-1264-2018
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) 113821-000, Serial Numbers: 10006997, 10002220 (b) 113821-600, Serial Numbers: 10002692,10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005189, 10005190, 10006891, 10004997, 10004327 (d) 114148-600, Serial Numbers: 10005201, 10006891
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.