Events

Recall of Device Recall Joerns

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
    35816
  • Event Risk Class
    Class 2
  • Event Number
    Z-0016-2007
  • Event Initiated Date
    2006-01-01
  • Event Date Posted
    2006-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46920
  • 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
    beds - Product Code FNL
  • Reason
    The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed.
  • Action
    The objective is to replace all of these systems. Phone contact of affected facilities began in January 2006. All facilities to be contacted by June 23, 2006. All products will be corrected at the location of the end-user by June 30, 2006.

Device

Device Recall Joerns
  • Model / Serial
    Model U 770, serial number range: 6149310001 - 6149310005, 6151360001 - 6151360005, 6163290001 - 616330001.  Model U770 AL, serial number range: 6099280001 - 6113410042, 6114760001 - 6127920006, 6128720001 - 6130360001, 6130510001 - 6135430002, 6136650001 - 6140860005, 6142190001 - 6142320001, 6142380001 - 6148440006, 6149320001 - 6151270004, 6152090001 - 6160890005, 6161480001 - 6162420010, 6163330001 - 6168440002, 6169170001 - 6171470001, 6171750001 - 6174080020, 6174750001 - 6177310002.   U770-GNDAL, serial number range: 6113510001 - 6113510004, 6127970001 - 61279700015, 6130370001 - 6130370003, 6135440001, 6140870001 - 61408700010, 6142330001, 6160900001 - 61609000010, 6168450001 - 6168450004, 6171700001 - 6171720002, 6174710001 - 61747100012.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
  • 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