Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0522-2014Class II

KayserBetten model IDA beds

mobility unlimited Inc dba kayserbetten US / initiated 2013-04-11 / Terminated / root cause: design

mobility unlimited inc began a recall of KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0522-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
mobility unlimited Inc dba kayserbetten US
Product
KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag
design
FDA root cause
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0522-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0522-2014Class IITerminatedVoluntary: Firm initiated