FDA Medical Device Recalls (openFDA)
Omega Medical Imaging, Inc.: Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
- Recall number
- Z-0160-2024
- Recalling firm
- Omega Medical Imaging, Inc.
- Product
- Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
- Status
- Open, Classified
- Initiated
- 2023-09-08
- Posted
- 2023-10-24
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 09/08/2023 via email. The notice explained the problem and the risk. The firm will inspect all affected devices to ensure the proper fasteners were installed on the unit.
- Quantity
- 31 units
- Distribution
- Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
- Lot, serial or model codes
- all units manufactured between 10-22-2012 and 07-09-2019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWE
- Firm FEI
- 1000222289
- Firm city
- Sanford
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28