FDA Medical Device Recalls (openFDA)
Omega Medical Imaging, Inc.: Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
- Recall number
- Z-2621-2017
- Recalling firm
- Omega Medical Imaging, Inc.
- Product
- Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
- Status
- Terminated
- Initiated
- 2017-03-23
- Posted
- 2017-06-19
- Terminated
- 2019-12-11
- Reason
- Elevating Monitor Suspension column dropping and will not rise back up.
- Root cause
- Mixed-up of materials/components
- Action
- The firm, OMEGA MEDICAL IMAGING, sent a "Field Safety Advisory Notice" dated 3/23/2017 to consignees. The notice described the product, problem and actions to be taken. The consignees were instructed to immediately examine the product and confirm correct product information; immediately discontinue use; move monitor suspension away from staff personnel and patients; and advising consignees to take photos of affected product and the P/N label. Photos of product labels are to be sent to jnewman@omegamedicalimaging.com at Omega. Product is to be corrected. If there are any questions or concerns, please feel free to contact us at 407-323-9400 Ext 203 or email: omegamedicalimaging.com or jnewman@omegamedicalimaging.com.
- Quantity
- 6 units
- Distribution
- Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
- Lot, serial or model codes
- SKF Telescopic Pillar P/N ending in -003
- 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