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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0522-2014 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
