Events

Recall of Device Recall Quickie Groove 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
    48662
  • Event Risk Class
    Class 2
  • Event Number
    Z-2339-2008
  • Event Initiated Date
    2006-11-13
  • Event Date Posted
    2008-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71843
  • 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
    Wheelchair - Product Code ITI
  • Reason
    Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.
  • Action
    Initial phone contacts began on November 13, 2006. Letters were also mailed. The letter informed the customer of the problem and provided interim steps to take, until an transit upgrade kit is installed. Response cards will be tracked to measure response rate and assure receipt of notice. Contact Sunrise Medical at 1-800-456-8168 for assistance.

Device

Device Recall Quickie Groove Power Wheelchair
  • Model / Serial
    Multiple serial numbers, starting with GRV-100: 182, 181, 178, 176, 166, 161, 160, 151, 150, 115, 110, 109, 106, 100, 099, 098, 094, 082, 081, 079, 076, 073, 064, 058, 056, 054, 053, 050, 044, 043, 041, 040, 035, 033, 021 and 013
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: US, Canada, New Zealand and Australia.
  • Product Description
    Sunrise Medical Quickie Groove Power Wheelchair with Transit option || The product is a powered wheelchair for human use.
  • Manufacturer
    Sunrise Medical Inc

Manufacturer

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