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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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
Related recalls
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