Z-0160-2024Class II

Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

Name: Z-0160-2024 Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Creator: Omega Medical Imaging, Inc.
Published: 2023-09-08
License: https://open.fda.gov/license/

Omega Medical Imaging, LLC / initiated 2023-09-08 / Open, Classified / root cause: design

FDA source

Omega Medical Imaging, Inc. began a recall of Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 on 2023-09-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0160-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-08
Posted: 2023-10-24
Recalling firm: Omega Medical Imaging, LLC
Product: Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Product code: IWE Monitor, Patient Position, Light-Beam
Reason for recall: 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 tag: design
FDA 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 in commerce: 31 units
Distribution: Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
Product codes and lots: all units manufactured between 10-22-2012 and 07-09-2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0160-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0160-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24

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)