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U.S. Department of Health and Human Services

Class 2 Device Recall ook snow,ook snow MH, ook cocoon

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  Class 2 Device Recall ook snow,ook snow MH, ook cocoon see related information
Date Initiated by Firm May 04, 2020
Create Date June 02, 2020
Recall Status1 Terminated 3 on December 30, 2020
Recall Number Z-2205-2020
Recall Event ID 85592
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product AC Powered hospital adjustable bed.
Code Information Model FL36 Numbers OL360011P or OL360017P
Recalling Firm/
Manufacturer		 Umano Medical, Inc.
230 Nilus-Leclerc Blvd
L'Islet Canada
For Additional Information Contact Maude Thibault
418-247-3986 Ext. 2242
Manufacturer Reason
for Recall		 Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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