Date Initiated by Firm | April 11, 2013 |
Date Posted | December 17, 2013 |
Recall Status1 |
Terminated 3 on October 08, 2014 |
Recall Number | Z-0522-2014 |
Recall Event ID |
65915 |
Product Classification |
Bed, ac-powered adjustable hospital - Product Code FNL
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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 PA 18102-2755
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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 | 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 |
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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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