CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
Elevating Monitor Suspension recalled by Omega Medical Imaging
Omega Medical Imaging is recalling Elevating Monitor Suspension, distributed nationwide in the US. The recall was initiated on 28 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0156-2024
- FDA event ID
- 93018
- Recalling firm
- Omega Medical Imaging, Sanford, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Feb 2023
- FDA classified
- 24 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 28 Feb 2023 | Recall initiated by company | |
| 24 Oct 2023 | Classified by FDA | +238 days |
| 1 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Where it was distributed
Worldwide distribution - US Nationwide and the country of Pakistan.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
all units manufactured between 10-22-2012 and 07-09-2019
Where was it sold?
Worldwide distribution - US Nationwide and the country of Pakistan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Omega Medical Imaging
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Elevating Monitor Suspension Systems recalled by Omega Medical Imaging | Omega Medical Imaging | Other | 11 states |
| Device | CLASS II | 2 over 2 Elevating Monitor Suspension pillar/column recalled | Omega Medical Imaging | Other | 4 states |
| Device | CLASS II | 2 over 2 Elevating Monitor Suspension recalled by Omega Medical Imaging | Omega Medical Imaging | Other | 14 states |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |