Z-2734-2016Class II

2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems

Name: Z-2734-2016 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems
Creator: Omega Medical Imaging, Inc.
Published: 2016-06-21
License: https://open.fda.gov/license/

Omega Medical Imaging, LLC / initiated 2016-06-21 / Terminated / root cause: design

FDA source

Omega Medical Imaging, Inc. began a recall of 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems on 2016-06-21. FDA classified it as Class II and gives the reason as "Elevating Monitor Suspension separated from the lifting column bracket". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2734-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-21
Posted: 2016-09-03
Terminated: 2019-10-04
Recalling firm: Omega Medical Imaging, LLC
Product: 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Product code: N/A
Reason for recall: Elevating Monitor Suspension separated from the lifting column bracket
Root cause tag: design
FDA 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 in commerce: 26 units
Distribution: CO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2734-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2734-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-03

Product code N/A

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)