Z-2205-2020 Class II Terminated

Recalled by Umano Medical, Inc. — L'Islet, N/A

Recall Details

Product Type
Devices
Report Date
June 10, 2020
Initiation Date
May 4, 2020
Termination Date
December 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3259 beds

Product Description

AC Powered hospital adjustable bed.

Reason for Recall

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

Distribution Pattern

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

Code Information

Model FL36 Numbers OL360011P or OL360017P