Events

Recall of Device Recall Quickie

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
    34155
  • Event Risk Class
    Class 2
  • Event Number
    Z-0518-06
  • Event Initiated Date
    2005-11-15
  • Event Date Posted
    2006-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43202
  • 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, Powered - Product Code ITI
  • Reason
    While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.
  • Action
    On November 9, 2005, the firm contacted its consignees via telephone, which was followed up by a mailing, to alert them of the situation. The firm is making arrangements to conduct the service correction at users'' residence. All appointmens are scheduled to be completed by December 15, 2005.

Device

Device Recall Quickie
  • Model / Serial
    Serial numbers: 1GMo1B5500522 1GL02B7500022, 1GL02B7500019, 1GM01B6500422, 1GL02B9400338
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    All 5 units were distributed to direct consignees, in CA, MA, NC, and OH.
  • Product Description
    Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; || Product is manufactured and distributed by || Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727
  • Manufacturer
    Sunrise Medical Inc

Manufacturer

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