Recall archive / FDA device enforcement
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 — FDA record Z-0160-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
- 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.
- Classification
- Class II
- Recalling firm
- Omega Medical Imaging, Inc.
- Quantity
- 31 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0160-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | all units manufactured between 10-22-2012 and 07-09-2019 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 1, 2023
- Recall initiation date
- Sep 8, 2023
- Center classification date
- Oct 24, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.