Device product
IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Z-1218-2018
Product summary
- Event
- Event 79366
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-1218-2018
Official wording
Reason: The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Code information: Serial numbers: 10005695, 10002998, 10005456, 10007411, 10007377, 10002997, 10002996, 10005612, 10004372, 10002841, 10004515, 10005613, 10002255
Distribution pattern: US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
Derived failure modes
-
Unknown
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.