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Z-2205-2020 Class II Terminated

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

FDA device recall Z-2205-2020 was initiated by Umano Medical, Inc. on May 4, 2020 and is designated Class II. Reason for recall: Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall. The recall status is terminated (terminated December 30, 2020). Affected quantity: 3259 beds.

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