ClearanceBrief
Recall Z-3211-2011 ยท INI Vehicle, Motorized 3-Wheeled

Pride Mobility Products Corp

Victory 10, 3 Wheel (SC610) Mobility medical device

DateSep 14, 2011 (initiated Jun 22, 2011)
StatusTerminated
ReasonContract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.
Root causeNonconforming 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
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,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K072165VICTORY THREE WHEEL SCOOTER, MODEL: SC610
Pride Mobility Products Corp., Aug 17, 2007