FDA Medical Device Recalls (openFDA)
Omega Medical Imaging, Inc.: 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
- Recall number
- Z-2734-2016
- Recalling firm
- Omega Medical Imaging, Inc.
- Product
- 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
- Status
- Terminated
- Initiated
- 2016-06-21
- Posted
- not on file
- Terminated
- 2019-10-04
- Reason
- Elevating Monitor Suspension separated from the lifting column bracket
- Root cause
- Device Design
- Action
- Consignees were notified by a Field Safety Advisory Notice - FSAN 16-0001 of this immediate Recall on 6/21/2016.
- Quantity
- 26 units
- Distribution
- CO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark
- Lot, serial or model codes
- Model: Elevating Monitor Suuspension P/Ns: 1000-0085, 1000-0095 and (1000-0129 one unit produced does not use bracket 1040-0071 or 1040-0031).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- 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