FDA Enforcement Class II Terminated

KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL

Recall: Z-0522-2014 · Reported December 25, 2013

Enforcement

Recall Number
Z-0522-2014
Event ID
65915
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
mobility unlimited inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
December 25, 2013
Initiation Date
April 11, 2013
Classification Date
December 16, 2013
Termination Date
October 8, 2014
Address
515 N 12th St, N/A, Allentown, PA, 18102-2755, United States

Description

KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL

Reason

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.

Code Info

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

Distribution

Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, FL, GA, IL, MN, MO, NY, PA, TN, TX, VA, and Canada.

Quantity

33 beds