Z-0975-2018 Class II Terminated
FDA device recall Z-0975-2018 was initiated by Deerfield Imaging, Inc. on February 20, 2018 and is designated Class II. Reason for recall: The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table. The recall status is terminated (terminated August 27, 2019). Affected quantity: 15 tables.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- February 20, 2018
- Termination Date
- August 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 tables
Product Description
IMRIS ORT100 Table, Part Number 110470-000
Reason for Recall
The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
Distribution Pattern
US, Canada, Australia, China, Qatar
Code Information
Serial Numbers: 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10002848, 10003241, 10005651, 10007348, 10007424, 10006886