Medical beds with motorized wheels face uncontrolled motion risk
Umano Medical recalls 228 adjustable hospital beds due to potential electrical system failure that could cause uncontrolled movement of the motorized wheel system.
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: This is an FDA Class II recall involving a theoretical risk of patient harm from uncontrolled motorized bed motion, but no injuries or deaths have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Umano Medical is recalling 228 AC-powered adjustable medical beds (Model FM1000) due to a potential hazard in the electrical system that could cause uninterrupted motion of the motorized wheel system.
The motorized wheel system is designed to be controlled and stationary when not in operation. A failure in a component of the electrical system could prevent the wheels from stopping, creating a risk of uncontrolled bed movement.
The recalled beds were distributed worldwide, including to 18 US states (California, Pennsylvania, Alabama, Georgia, Arizona, Minnesota, Florida, Washington, Oklahoma, New York, North Dakota, Arkansas, Missouri, North Carolina, Utah, Texas, and Wisconsin) as well as Australia, Ireland, and Canada.
Umano Medical is contacting facilities and users of the affected beds directly. Consumers or facilities with a recalled bed should stop using it and contact Umano Medical immediately for instructions on repair or replacement options.
The recalled product
- Product
- AC-powered adjustable medical beds with built-in electric DC actuators and controls.
- Manufacturer
- Umano Medical, Inc.
- Category
- Medical Device
- Hazard
- uncontrolled-motion
- electrical-failure
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 (20)
- Model number: FM1000
- UDI: 00670482000487
- Serial Numbers: FM100000704
- FM100000703
- FM100000716
- FM100000715
- FM100000714
- FM100000713
- FM100000712
- FM100000711
- FM100000710
- FM100000709
- FM100000708
- FM100000707
- FM100000706
- FM100000705
- FM100000702
- FM100000701
- FM100000700
- FM100000699
Distribution
Distributed nationwide across the United States.
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