Recall Z-1136-2022— Umano Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Umano Medical, Inc., initiated 2022-04-11, terminated 2024-01-17. FDA's recall record names no specific 510(k) clearance for this event. Product: AC-powered adjustable medical beds with built-in electric DC actuators and controls.. Reason: There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product..
- Recalling firm
- Umano Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-04-11
- Terminated
- 2024-01-17
- Firm location
- L'Islet, Canada
Product description
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Reason for recall
There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.