Events

Recall of QLogic Controller Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pride Mobility Products Corp.

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
    47807
  • Event Risk Class
    Class 2
  • Event Number
    Z-1776-2008
  • Event Initiated Date
    2008-04-11
  • Event Date Posted
    2008-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70265
  • 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
    Powered Wheelchair - Product Code ITI
  • Reason
    Software - watch dog timer feature was disabled.
  • Action
    The recalling firm issued an Urgent Device Correction letter on 4/11/08. This letter instructs the dealers to contact the end users so that the units can be upgraded to enable the watch dog feature.

Device

QLogic Controller Software
  • Model / Serial
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- including USA and Canada.
  • Product Description
    Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

Pride Mobility Products Corp
  • Manufacturer Address
    Pride Mobility Products Corp, 182 Susquehanna Ave, Exeter PA 18643-2653
  • Manufacturer Parent Company (2017)
    Pride Mobility Products Corp
  • Source
    USFDA