Omega Medical Imaging Monitor Suspension Systems Recalled for Boom Detachment Risk
Omega Medical Imaging recalls monitor boom systems where the actuator can separate from the pivot mechanism, allowing the boom to detach. The defect affects units manufactured between October 2012 and July 2019.
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: This is an FDA Class II medical device recall involving a structural failure of medical imaging support equipment. Although no injuries have been reported and a safety cable prevented the documented incident, the defect creates a risk of equipment detachment that could cause harm in a healthcare environment.
Plain-English summary
Omega Medical Imaging, Inc. is recalling its Elevating Monitor Suspension Systems, Part Number 1000-0085, used in medical imaging facilities. The systems are distributed across eleven states: Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, and Oklahoma.
The systems contain an actuator that can separate from the pivot mechanism on the lower monitor boom. This separation could allow the boom to detach from the column. In the documented case, the boom separation was prevented by an installed safety cable.
Approximately 31 units are affected, all manufactured between October 22, 2012 and July 9, 2019. Customers with this equipment should contact Omega Medical Imaging, Inc. immediately. Healthcare facilities should verify that safety cables are properly installed and ensure the equipment is properly secured pending inspection or service.
The recalled product
- Product
- Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
- Manufacturer
- Omega Medical Imaging, Inc.
- Affected units
- 31
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)
- all units manufactured between 10-22-2012 and 07-09-2019
Distribution
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