Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Victory 10, 3 Wheel (SC610)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Victory 10, 3 Wheel (SC610)see related information
Date Initiated by FirmJune 22, 2011
Date PostedSeptember 14, 2011
Recall Status1 Terminated 3 on November 20, 2014
Recall NumberZ-3211-2011
Recall Event ID 59438
510(K)NumberK072165 
Product Classification Vehicle, motorized 3-wheeled - Product Code INI
ProductVictory 10, 3 Wheel (SC610) Mobility medical device
Code Information Victory 10, 3 Wheel 
Recalling Firm/
Manufacturer		 Pride Mobility Products Corp
182 Susquehanna Ave
Exeter PA 18643
For Additional Information ContactCustomer Support
800-800-8586
Manufacturer Reason
for Recall		Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPride 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. .
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = INI
-
-