Events

Recall of Device Recall Quickie Rhythm Power Wheelchair

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
    46908
  • Event Risk Class
    Class 2
  • Event Number
    Z-1531-2008
  • Event Initiated Date
    2008-01-11
  • Event Date Posted
    2008-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68463
  • 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
    Powered Wheelchair - Product Code ITI
  • Reason
    Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.
  • Action
    Initial phone contact began on January 11, 2008. Medical device correction letters were also sent to affected dealers.

Device

Device Recall Quickie Rhythm Power Wheelchair
  • Model / Serial
    All wheelchairs with the QC Motor controller units with version 2.0 parameter or *.SUN file software.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 126 retailers nationwide throughout the USA, as well as Canada and Australia.
  • Product Description
    Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10
  • Manufacturer
    Sunrise Medical Inc

Manufacturer

Sunrise Medical Inc
  • Manufacturer Address
    Sunrise Medical Inc, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Source
    USFDA