Events

Recall of Device Recall Padded, swingaway armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs

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
    62493
  • Event Risk Class
    Class 2
  • Event Number
    Z-2113-2012
  • Event Initiated Date
    2012-06-26
  • Event Date Posted
    2012-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110756
  • 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
    Reports of injury when the padded swing away armrest is used for full body weight. owner's manual states that armrest is only designed for resting of forearm.
  • Action
    Sunrise Medical sent a Safety Notice letter dated June 25, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter request that clinicians/suppliers post this safety notice in a conspicuous location, making customers and therapists aware of the issue. The letter also encourage end users to read the owner's manual and follow the recommenations for proper usage of the recalled product. Customers are instructed to complete and return the Supplier Notification and Response Form. For questions contact Sunrise Medical Regulatory Affairs at 888-208-4901.

Device

Device Recall Padded, swingaway armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs
  • Model / Serial
    Receiver Product number 109207.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
  • Product Description
    Padded Swing Away Arm Rest with Receiver; || Uses on wheelchair models: || Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). || Product Usage: || To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
  • 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