Events

Recall of Device Recall Joerns Easy Care bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunrise Medical CCG, 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
    35922
  • Event Risk Class
    Class 3
  • Event Number
    Z-1412-06
  • Event Initiated Date
    2005-11-16
  • Event Date Posted
    2006-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47183
  • 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
    Hospital Bed powered adjustment - Product Code FNL
  • Reason
    Malfunction- the easy care drive system performance, controlling back and knee section angle adjustment, as well as, bed height adjustment could become non-functional .
  • Action
    End-user facilities were contacted by Sunrise Medical Customer Service Team via telephone. All beds were inspected and corrected by factory-trained representatives or by affected locations'' facility engineers.

Device

Device Recall Joerns Easy Care bed
  • Model / Serial
    Models: B684 & B684DC -Serial numbers: 101204, 101804, 101904, 102004, 102104, 102204, 102504, 102604, 102804, 102904, 110104, 111204.---Model B694, Serial number: 113004.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution -including states of AZ, CA, CO, FL, IA, KY, MA, MO, MS, NC, ND, OH, OK, SC, TN, TX, VA, WI, and WV.
  • Product Description
    Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds
  • Manufacturer
    Sunrise Medical CCG, Inc.

Manufacturer

Sunrise Medical CCG, Inc.
  • Manufacturer Address
    Sunrise Medical CCG, Inc., 5501 Joerns Dr, Stevens Point WI 54481-5011
  • Source
    USFDA