FDAFDA · Food and drugs·Recall number Z-2205-2020
AC Powered hospital adjustable bed.
Published June 10, 2020 · Recall initiated: May 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Umano Medical, Inc.
- Distributor
- Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.
- Lot
- Model FL36 Numbers OL360011P or OL360017P
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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