AC Powered hospital adjustable bed.
Recall
- Recall Number
- Z-2205-2020
- Event Number
- 85592
- Firm
- Umano Medical, Inc.
- FEI Number
- 3009591865
- Product Code
- FNL
- Status
- Terminated
- Root Cause
- Use error
- Initiated
- May 4, 2020
- Terminated
- December 30, 2020
- Address
- 230 Nilus-Leclerc Blvd, L'Islet Canada
Description
AC Powered hospital adjustable bed.
Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.
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.
Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.
3259 beds