Recall Z-1265-2018 ยท FQO Table, Operating-Room, Ac-Powered
Deerfield Imaging, Inc.
IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
| Date | Feb 23, 2018 |
| Status | Terminated |
| Reason | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. |
| Root cause | Other |
| Action | The firm initiated their field notification on 02/23/2018 by letter. The notice stated the following: "It has recently come to our attention that the ORTT2X/100/200/300 tables may drift while in use, which could potentially result in unintended movement of the table. This may pose a risk of injury to the patient. To minimize these risks, IMRIS is taking the following corrective actions: " ORT T2X/100/200 tables: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do not pass the drift test, a hydraulc fluid flush a |
| Quantity | 14 units |
| Distribution | US, Canada, China, Australia, Sweden, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.