Events

Recall of KayserBetten

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by mobility unlimited inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65915
  • Event Risk Class
    Class 2
  • Event Number
    Z-0522-2014
  • Event Initiated Date
    2013-04-11
  • Event Date Posted
    2013-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120843
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 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.
  • 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.

Device

KayserBetten
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    KayserBetten model IDA beds || Product Usage: || BED, AC-POWERED ADJUSTABLE HOSPITAL
  • Manufacturer
    mobility unlimited inc

Manufacturer

mobility unlimited inc
  • Manufacturer Address
    mobility unlimited inc, 515 N 12th St, Allentown PA 18102-2755
  • Manufacturer Parent Company (2017)
    Mobility Unlimited Inc.
  • Source
    USFDA