Device product
IMRIS ORT200 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-1217-2018
Product summary
- Event
- Event 79366
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-1217-2018
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: 10006997, 10002692, 10006152, 10007192, 10006991, 10002220, 10003754, 10006997, 10004513, 10005201, 10006891, 10004463, 10005189, 10005190, 10004327, 10004997, 10006891
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.