FDA recall Z-2205-2020

Umano Medical, Inc. · Class II · device

Product

AC Powered hospital adjustable bed.

Reason for recall

Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.

Distribution

Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.

Key facts

Status
Terminated
Initiation date
2020-05-04
Report date
2020-06-10
Termination date
2020-12-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
L'Islet, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2205-2020