Z-2621-2017Class II

Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that...

Name: Z-2621-2017 Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that...
Creator: Omega Medical Imaging, Inc.
Published: 2017-03-23
License: https://open.fda.gov/license/

Omega Medical Imaging, LLC / initiated 2017-03-23 / Terminated

FDA source

Omega Medical Imaging, Inc. began a recall of Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals on 2017-03-23. FDA classified it as Class II and gives the reason as "Elevating Monitor Suspension column dropping and will not rise back up". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2621-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-23
Posted: 2017-06-19
Terminated: 2019-12-11
Recalling firm: Omega Medical Imaging, LLC
Product: Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
Product code: IWE Monitor, Patient Position, Light-Beam
Reason for recall: Elevating Monitor Suspension column dropping and will not rise back up.
FDA 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 [email protected] 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 [email protected].
Quantity in commerce: 6 units
Distribution: Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
Product codes and lots: SKF Telescopic Pillar P/N ending in -003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2621-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2621-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-22

Product code IWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)