Recall Z-0160-2024 ยท IWE Monitor, Patient Position, Light-Beam
Omega Medical Imaging, Inc.
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
| Date | Oct 24, 2023 (initiated Sep 8, 2023) |
| Status | Open, Classified |
| Reason | An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable. |
| Root cause | Device Design |
| Action | Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 09/08/2023 via email. The notice explained the problem and the risk. The firm will inspect all affected devices to ensure the proper fasteners were installed on the unit. |
| Quantity | 31 units |
| Distribution | Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.