Class II — Omega Medical Imaging, Inc.
| Recalling firm | OMEGA MEDICAL IMAGING, LLC |
|---|---|
| Registered facility | OMEGA MEDICAL IMAGING, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 |
| Quantity | 31 units |
| Distribution | Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma |
| Initiated | 2023-09-08 |
| Classified | 2023-10-24 |
| Recall number | Z-0160-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Omega Medical Imaging, Inc. (Z-0160-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93123/
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