Events

Recall of Device Recall Victory 10, 3 Wheel (SC610)

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
    59438
  • Event Risk Class
    Class 2
  • Event Number
    Z-3211-2011
  • Event Initiated Date
    2011-06-22
  • Event Date Posted
    2011-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102794
  • 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
    Vehicle, motorized 3-wheeled - Product Code INI
  • Reason
    Contract manufacturer error. component part(s) (fuses) specifications were not adhered to as outlined in pride's engineering drawings.
  • Action
    Pride Mobility Products Corp. sent a "RECALL OF VICTORY 3 AND 4 WHEEL UNITS; REPLACEMENT OF FUSES" letter dated June 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are asked in the letter to locate their affected Victory unit(s) and inform users of the recall. A letter has been provided by the firm to distribute to users alerting them to the recall. Additionally, customers are to set up an appointment with users to replace the fuses. Customers are instructed to contact Pride's Upgrade department at 866-222-6212 to order the kit and for questions regarding this recall. .

Device

Device Recall Victory 10, 3 Wheel (SC610)
  • Model / Serial
    Victory 10, 3 Wheel
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the District of Columbia and Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Australia, Canada, France, and United Kingdom.
  • Product Description
    Victory 10, 3 Wheel (SC610) || Mobility medical device
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

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