Recall Z-1135-2022 ยท FNL Bed, Ac-Powered Adjustable Hospital
Umano Medical, Inc.
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
| Date | Apr 11, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent out the recall notification to the consignees on 04/11/2022 via email. The letter instructs the users to avoid using the product and forward the notice to any affected users. The letter directed to the distributors instructs them to stop distribution of the product, send the notice to users of the product, and send a report to the manufacturer conforming inventory and contact information for each site that was contacted. |
| Quantity | 228 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, PA, AL, GA, AZ, MN, FL, WA, OK, NY, ND, AR, MO, NC, UT, TX, WI, and the countries of Australia, Ireland, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.