The Recall Desk
HighFDA (Devices)·Z-2734-2016·Announced 2016-09-14

Omega Medical Imaging Recalls Elevating Monitor Suspension Systems

Omega Medical Imaging is recalling 26 Elevating Monitor Suspension Systems because the suspension may separate from the lifting column bracket.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device where a component may separate, posing a risk of harm, but the source text does not report any injuries or illnesses.

Plain-English summary

Omega Medical Imaging, Inc. is recalling 26 units of the 2 over 2 Elevating Monitor Suspension Systems. The recall was initiated because the Elevating Monitor Suspension may separate from the lifting column bracket.

The affected products are identified by Model: Elevating Monitor Suspension and Part Numbers 1000-0085, 1000-0095, and 1000-0129. One unit produced with Part Number 1000-0129 does not use bracket 1040-0071 or 1040-0031.

The recalled units were distributed in Colorado, Minnesota, Georgia, North Carolina, Indiana, Ohio, Kentucky, Illinois, New York, Alabama, Missouri, Louisiana, Pennsylvania, South Dakota, and Denmark. The source text does not specify instructions for consumers or healthcare facilities regarding the next steps for this recall.

The recalled product

Product
2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Manufacturer
Omega Medical Imaging, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model: Elevating Monitor Suuspension P/Ns: 1000-0085

Distribution

Distributed in 14 states:

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