Recall Z-2205-2020 ยท FNL Bed, Ac-Powered Adjustable Hospital
Umano Medical, Inc.
AC Powered hospital adjustable bed.
| Date | May 4, 2020 |
| Status | Terminated |
| Reason | Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall. |
| Root cause | Use error |
| Action | The firm sent a Medical Device Recall-User Manual letter dated May 4,2020 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify affected units. Units bearing the options numbers OL360011P or OL360017P and manufactured between January 26th, 2015 and January 24rd,2020 were packaged with a User Manual affected by this recall and subject to improvement with the attached addendum. A list of serial numbers traced as being in your facility is attached to this communication. The manufacturing date and serial number are locate |
| Quantity | 3259 beds |
| Distribution | Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.