Recall Z-0156-2024 ยท IWE Monitor, Patient Position, Light-Beam
Omega Medical Imaging, Inc.
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
| Date | Oct 24, 2023 (initiated Feb 28, 2023) |
| Status | Open, Classified |
| Reason | An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location. |
| Root cause | Device Design |
| Action | Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 02/28/2023 by email. The notice explained the issue and pledged to evaluate all potentially impacted devices and mitigate the issue to bring the boom systems up to the latest safety design and standard of the newer models approved for field use. |
| Quantity | 52 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Pakistan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.