Events

Recall of Device Recall Quickie Q7 wheelchair. Model EIR4

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunrise Medical (US) LLC.

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
    74596
  • Event Risk Class
    Class 2
  • Event Number
    Z-2290-2016
  • Event Initiated Date
    2016-07-01
  • Event Date Posted
    2016-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148019
  • 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, mechanical - Product Code IOR
  • Reason
    There is an observed failure of the backrest bracket which can fatigue over the life time of the product. when this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame.
  • Action
    The firm began calling dealers to alert them to the recall and obtain primary contacts information. Dealers were then sent their list of Quickie Q7 wheelchairs that records show being sold by them and dealers are asked to return a list of chairs they are able to locate for correction. The first dealer letter was sent via e-mail on July 7, 2016.

Device

Device Recall Quickie Q7 wheelchair. Model EIR4
  • Model / Serial
    Model EIR 4 13,000 + serial numbers. RES would not accept this number. Please see spreadsheet provided in documents.R4-007239 to R4-022394. Serial number range:
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US and Mexico, Japan, Chile, Kuwait, Columbia, Hong Kong, China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles, British Virgin Islands,
  • Product Description
    Quickie Q7 wheelchair. Model EIR4 || Physical Medicine. || The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
  • Manufacturer
    Sunrise Medical (US) LLC

Manufacturer

Sunrise Medical (US) LLC
  • Manufacturer Address
    Sunrise Medical (US) LLC, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Manufacturer Parent Company (2017)
    Sunrise Medical (Us) Llc
  • Source
    USFDA