Recall Z-0975-2018 ยท KXJ Table, Radiologic
Deerfield Imaging, Inc.
IMRIS ORT100 Table, Part Number 110470-000
| Date | Feb 20, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | The firm disseminated the notices on 02/23/2018 and followed with emails on 02/26/2018. The notices stated: "To minimize the risk of injury, IMRIS is taking the following corrective actions: " ORT100 Table: The rotational locking mechanism shall be replaced in all ORT100 tables that do not contain the most current design. " T2X Table: Tables will have their rotational lock inspected. If components are worn or performance is other than intended, the rotational lock assembly will be serviced or replaced entirely. IMRIS has identified that your facility has one or more of these OR Tables which |
| Quantity | 15 tables |
| Distribution | US, Canada, Australia, China, Qatar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.