Omega Medical Imaging Elevating Monitor Suspension Systems — Class II medical device recall Z-0160-2024
Ongoing recall by Omega Medical Imaging, Inc., reported 2023-11-01, distributed in AL, CA, IL, IN, KY, LA, MO, MT…. An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became de
| Recall number | Z-0160-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Omega Medical Imaging, Inc., Sanford, FL, United States |
| Recall initiated | 2023-09-08 |
| Classified | 2023-10-24 |
| Reported by FDA | 2023-11-01 |
| Distributed | AL, CA, IL, IN, KY, LA, MO, MT, NC, OH, OK |
| Quantity | 31 units |
| Reason classes | device malfunction |
| Model numbers | 1000-0085 |
Product
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0160-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.