Recall Z-2584-2021 ยท KXJ Table, Radiologic
Deerfield Imaging, Inc.
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
| Date | Aug 25, 2021 |
| Status | Terminated |
| Reason | ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. |
| Root cause | Device Design |
| Action | A Recall notification letter titled, "URGENT FIELD CORRECTION NOTICE" was sent to consignees on 08/25/2021 via Fed-Ex. E-mail communications were also sent to the customers on 8/26/2021. The letter instructs the consignee to fill out the second page of the notice and return it to the firm. The letter states that the IMRIS Customer Service will contact the consignee to schedule implementation of this corrective action with the facility. The letter mentions that, "IMRIS recommends these preventive actions: Per the OR Table Operator Manuals, the table should be tested daily in all standard posit |
| Quantity | 13 units |
| Distribution | Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.