Omega Medical Imaging Recalls Elevating Monitor Suspension Pillars
Omega Medical Imaging is recalling 6 units of 2 over 2 Elevating Monitor Suspension pillars because the column may drop and fail to rise.
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 mechanical failure of a medical device accessory that poses a risk of harm (dropping equipment) but does not meet the criteria for Severe (no hospitalization or structural vehicle defect) or Critical (no FDA Class I or fatalities).
Plain-English summary
Omega Medical Imaging, Inc. is recalling 6 units of the 2 over 2 Elevating Monitor Suspension pillar/column accessory. The recall is due to a defect where the elevating column may drop and will not rise back up.
The affected product is a device accessory used to elevate monitors for healthcare professionals. The specific units involved are identified by the SKF Telescopic Pillar part number ending in -003.
Distribution of the recalled units was worldwide, with specific US distribution to Indiana, Ohio, Pennsylvania, and Montana, as well as distribution to Pakistan. Healthcare professionals and consumers who possess these specific units should stop using them and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
- Manufacturer
- Omega Medical Imaging, Inc.
- Affected units
- 6
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)
- SKF Telescopic Pillar P/N ending in -003
Distribution
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