Recall Z-1217-2018 ยท FQO Table, Operating-Room, Ac-Powered
Deerfield Imaging, Inc.
IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
| Date | Feb 23, 2018 |
| Status | Terminated |
| Reason | The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked. |
| Root cause | Under Investigation by firm |
| Action | The firm disseminated their notices on 02/23/2018 by mail and followed with an email on 02/26/2018. The notice stated: "It has recently come to our attention that the ORT200/300 rotational lock fails to operate such that it cannot change states between locked and unlocked. This may pose a risk of injury to the patient. To minimize the risk of injury, IMRJS is taking the following corrective actions: " ORT200 and 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary. IMRIS has identified that your facility has one or mo |
| Quantity | 17 units |
| Distribution | US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.