Events

Recall of Device Recall Zippie TS wheelchair

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
    61082
  • Event Risk Class
    Class 2
  • Event Number
    Z-1103-2012
  • Event Initiated Date
    2012-01-13
  • Event Date Posted
    2012-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107257
  • 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
    One zippie ts wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use.
  • Action
    Sunrise Medical contacted customer by telephone on January 17, 2012 to arrange for removal of transit brackets. The Sunrise Sales rep then visited the customers on January 18, 2012 and removed the bracket from the chair making it appropriate for intended use. If you need any additional information or have any questions, call 559-348-2572 or email: laurie.roberts@sunmed.com.

Device

Device Recall Zippie TS wheelchair
  • Model / Serial
    Model number: E1Z1A; Serial number: Z1SE-006474.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: OK only.
  • Product Description
    Sunrise Medical Zippie TS wheelchair || To empower physically challenged person by providing a means or mobility.
  • 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