FDA Medical Device Recalls (openFDA)
Omega Medical Imaging, Inc.: Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
- Recall number
- Z-0156-2024
- Recalling firm
- Omega Medical Imaging, Inc.
- Product
- Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
- Status
- Open, Classified
- Initiated
- 2023-02-28
- Posted
- 2023-10-24
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 02/28/2023 by email. The notice explained the issue and pledged to evaluate all potentially impacted devices and mitigate the issue to bring the boom systems up to the latest safety design and standard of the newer models approved for field use.
- Quantity
- 52 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Pakistan.
- 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