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U.S. Department of Health and Human Services

Class 2 Device Recall KayserBetten

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 Class 2 Recall
KayserBetten
see related information
Date Posted December 17, 2013
Recall Status1 Terminated on October 08, 2014
Recall Number Z-0522-2014
Recall Event ID 65915
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
Code Information Serial Nos.: 227.15.03s.-00.-07.10.0726/1998 228.15.03S.-00.-06.09.0562/1998 227.15.03s.-00.-07.10.0725/1998 227.15.03S.-55.-03.11.0141/1998 227.15.03S.-55.-03.11.0142/1998 226.15.03S.-00.-06.09.0557/1998 228.15.03S.-00.-06.09.0563/1998 225.02.03s.-35.-07.10.0733/1998 227.15.03S.-00.-06.09.0569/1998 227.15.03S.-00.-06.09.0572/1998 227.15.03S.-00.-06.09.0714/1998 228.15.03S.-00.-06.09.0559/1998 228.15.03S.-00.-06.09.0713/1998 227.15.03S.-00.-06.09.0567/1998 227.15.03S.-00.-06.09.0570/1998 228.15.03S.-00.-06.09.0560/1998 225.15.03s.-00.-07.10.0724/1998 228.15.03S.-00-.12.08.1366/1998 228.15.03S.-00.-06.09.0564/1998 225.15.03S.-00.-06.09.0565/1998 225.15.03S.-00.-06.09.0566/1998 225.02.03s.-35.-07.10.0685/1998 225.15.03s.-00.-07.10.0723/1998 227.15.03S.-00.-06.09.0571/1998 227.15.03S.-55.-03.11.0144/1998 225.02.03s.-35.-07.10.0686/1998 226.15.03S.-00.-06.09.0558/1998 225.15.03s.-00.-07.10.0732/1998 227.15.03S.-00.-12.08.1363/1998 227.15.03S.-55.-03.11.0143/1998 225.02.03s.-35.-07.10.0684/1998 225.15.03s.-00.-07.10.0731/1998 228.15.03S.-00.-06.09.0561/1998
Recalling Firm/
Manufacturer
mobility unlimited inc
515 N 12th St
Allentown, Pennsylvania 18102-2755
For Additional Information Contact Mobility Unlimited Customer Service
610-433-8797
Manufacturer Reason
for Recall
Some joints on the doors of a limited number of IDA beds may loosen or separate over time which can cause the doors to drop outward and cause injury.
FDA Determined
Cause 2
DESIGN: Device Design
Action Mobility Unlimited sent a notification letters dated April 12, 2013 to affected customers The letter identified the affected product, problem and actions to be taken. The letter informed customers that a Retrofit Kits along with illustrated instructions will be sent. For questions call 1-800-574-7880.
Quantity in Commerce 33 beds
Distribution Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, FL, GA, IL, MN, MO, NY, PA, TN, TX, VA, and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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