Omega Medical Imaging Monitor Suspension Actuator Separation Risk
Omega Medical Imaging is recalling 52 monitor suspension systems (Part Number 1000-0085) manufactured 2012–2019 in which the actuator may separate from the pivot mechanism. An installed safety cable contained one such failure, but the structural issue poses a falling hazard. No injuries reported.
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: Class II medical device recall involving structural failure of a critical suspension component. The actuator separation demonstrates a risk-of-harm condition in equipment where failure could result in monitor falling and potential injury. No injuries reported to date, but actual failure occurred.
Plain-English summary
Omega Medical Imaging, Inc. is recalling 52 units of its Elevating Monitor Suspension, Model 1000-0085, used to mount and position medical imaging monitors in clinical facilities.
The company discovered that the actuator on the lower monitor boom system column can separate from its pivot mechanism and become detached. An installed safety cable restrained the detached actuator in one reported case, preventing immediate harm. However, the structural failure indicates a risk that the suspension system could fail to safely support the monitor.
The affected devices were manufactured between October 22, 2012, and July 9, 2019, and distributed worldwide, including to the United States and Pakistan. All 52 units produced during this period are included in the recall.
As of the recall announcement, no injuries or illnesses have been reported in connection with this issue.
The recalled product
- Product
- Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
- Manufacturer
- Omega Medical Imaging, Inc.
- Affected units
- 52
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
Distributed nationwide across the United States.
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