Z-2205-2020Class II

AC Powered hospital adjustable bed

Name: Z-2205-2020 AC Powered hospital adjustable bed
Creator: Umano Medical, Inc.
Published: 2020-05-04
License: https://open.fda.gov/license/

Umano Medical Inc. / initiated 2020-05-04 / Terminated

FDA source

Umano Medical, Inc. began a recall of AC Powered hospital adjustable bed on 2020-05-04. FDA classified it as Class II and gives the reason as "Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2205-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-04
Posted: 2020-06-02
Terminated: 2020-12-30
Recalling firm: Umano Medical Inc.
Product: AC Powered hospital adjustable bed.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.
FDA 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 located on the manufacturer label located at the head end of the device. Actions Needed: 1. Please carefully read the attached addendum and promptly disseminate its contents to all concerned personnel in your facility, including more importantly to all persons who are or may be called upon to use/operate the bed. 2. Locate the User Manual related to your FL36 bed and insert the addendum, for future reference, in the appropriate section of the instruction manual for the FL36 ook-snow, ook-snow MH or ook-cocoon beds. 3. If you have loaned or sold any of the beds listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location. 4. If you have disposed of any of the affected beds and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. 5. Call at 1-844-409-4030 or at 1-418-247-3986, extension 4 to confirm that your facility received Umano Medical Inc.s addendum to the User Manual regarding the Zeroing Procedure and the Detection System applicable to the above-mentioned product(s) and that the Actions Needed have been taken and completed by your facility.
Quantity in commerce: 3259 beds
Distribution: Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.
Product codes and lots: Model FL36 Numbers OL360011P or OL360017P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2205-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2205-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)