Events

Recall of Device Recall Sunrise MedicalHoyer Advance Patient Lifts

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Joerns Healthcare 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
    37641
  • Event Risk Class
    Class 2
  • Event Number
    Z-0727-2007
  • Event Initiated Date
    2007-02-21
  • Event Date Posted
    2007-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51204
  • 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
    Patient Lift - Product Code FSA
  • Reason
    Unapproved design change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).
  • Action
    Recall initiated by letter dated 2/21/2007. Sunrise Medical will schedule onsite appointments to complete the base replacement.

Device

Device Recall Sunrise MedicalHoyer Advance Patient Lifts
  • Model / Serial
    1)-Model Number : Hoy - Advance - E with Serial numbers: 0601L0433 through 0601L0441, 0603L0294 through 0603L0336, 0603L0493 through 0603L0501, 0603L1011 through 0603L1021, 0603L1139 through 0603L1187, 0603L1285 through 0603L1294, 0604L0394 through 0604L0411, 0604L0885 through 0604L0941, 0604L1002 through 0604L1012, 0606L0365 through 0606L0431, 0606L0789 through 0606L0818, 0606L1006 through 0606L1030, and 0607L0001 through 0607L0090--2)Model Number: Hoy - Advance - H with Serial numbers: 0601L0442 through 0601L0459, 0603L0286 through 0603L0293, 0603L1022 through 0603L1041, 0603L1295 through 0603L1330, 0603L1519 through 0603L1572, 0605L0742 through 0605L0753, 0606L0049 through 0606L0142, 0606L0819 through 0606L0848, and 0606L1031 through 0606L1144
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and country of Canada.
  • Product Description
    Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc.
  • Manufacturer
    Joerns Healthcare Inc.

Manufacturer

Joerns Healthcare Inc.
  • Manufacturer Address
    Joerns Healthcare Inc., 5001 Joerns Dr, Stevens Point WI 54481-5011
  • Source
    USFDA