Recall Z-0645-2019 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, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended
| Date | Nov 6, 2018 |
| Status | Terminated |
| Reason | Table may drift in the roll position while in use |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by letter on 11/06/2018. The letter explained the issue, requested the consignee follow the recommended daily test in all positions until the roll cylinders are exchanged. |
| Quantity | 15 units |
| Distribution | Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.