Events

Recall of Device Recall Zippie Zone Pediatric Rigid 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
    70141
  • Event Risk Class
    Class 2
  • Event Number
    Z-1019-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132316
  • 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 the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
  • Action
    Sunrise Medical sent an Urgent Medical Device Field Correction letters dated December 19, 2014 to the two affected distributors. The letter identified the affected product, problem and actions to be taken. For question contact Sunrise Medical Regulatory Affairs at either (559)294-2840.

Device

Device Recall Zippie Zone Pediatric Rigid Wheelchair
  • Model / Serial
    Serial numbers: RZ-006261, RX-009856, RZ-005964
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution in the states of CO and ME.
  • Product Description
    Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
  • Manufacturer
    Sunrise Medical (US) LLC

Manufacturer

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