Events

Recall of Device Recall Hydraulic and battery powered patient lifts

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunrise Medical, 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
    31124
  • Event Risk Class
    Class 2
  • Event Number
    Z-0785-05
  • Event Initiated Date
    2005-02-03
  • Event Date Posted
    2005-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37193
  • 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
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • Reason
    The leg actuation mechanism on certain hoyer advance patient lifts may not operate properly, which could cause the lift to become unstable.
  • Action
    Telephone calls were placed to customers on 02/03/05. Urgent Medical Device Correction letters, dated 02/03/05, were also sent to customers.

Device

Device Recall Hydraulic and battery powered patient lifts
  • Model / Serial
    Model: Hoy-Advance-E; Serial Numbers: 0409L2383, 0409L2384, 0411L001-0411L0023.  Model: Hoy-Advance-H; Serial Numbers: 0409L2341-0409L2380, 0410L0680-0410L0727, 0410L0781-0410L0862.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Domestic distribution: WI, FL, GA, TX, OK. Foreign distribution: Canada. No military or VA facilities
  • Product Description
    Sunrise Hoyer Advance Patient lifts
  • Manufacturer
    Sunrise Medical, Inc.

Manufacturer

Sunrise Medical, Inc.
  • Manufacturer Address
    Sunrise Medical, Inc., 7477 East Dry Creek Parkway, Longmont CO 80503
  • Source
    USFDA