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 Freedom Designs TriPod w/Anti tipper Manual Wheelchair

  • 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 Freedom Designs TriPod w/Anti tipper Manual Wheelchair see related information
Date Initiated by Firm May 14, 2007
Date Posted December 19, 2007
Recall Status1 Terminated 3 on July 14, 2008
Recall Number Z-0137-2008
Recall Event ID 44928
510(K)Number K060926  
Product Classification Wheel Chair - Product Code IOR
Product Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065
Code Information Serial numbers: LTP-90088, LTP-90090, LTP-90092, LTP-90095, LTP-90105, LTP-90106, LTP-90107, LTP-90108, LTP-90109, LTP-90110, LTP-90111, LTP-90112, LTP-90113, LTP-90114, LTP-90115, LTP-90117, LTP-90118,  LTP-90119, LTP-90122, LTP-90127, LTP-90130, LTP-90131, LTP-90134, LTP-90135, LTP-90136, LTP-90138, LTP-90139, LTP-90140, LTP-90141, LTP-90142, LTP-90143, LTP-90146, LTP-90147, LTP-90149, LTP-90150,  LTP-90151, LTP-90152, TP-30153, TP-30013, TP-30025, TP-30136  
Recalling Firm/
Manufacturer		 Freedom Designs Inc
2241 N Madera Rd
Simi Valley CA 93065-1762
For Additional Information Contact Bob Gardner
805-915-1105
Manufacturer Reason
for Recall		 Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.
FDA Determined
Cause 2		 Process control
Action Urgent Field Correction Notification letters were sent to customers on May 15, 2007 via US Postal return receipt requested. Consignees were notified via delivery of a field correction package consisting of: (1) A letter to the dealer (2) FAQ sheet clarifying their responsibility (3) A corrective/preventive action tracking sheet specific for the consignees affected units (4) Replacements of anti-tipper assembly for each unit shipped with an instruction sheet. A Notice was also posted on the Freedom Designs website. Correction will be made to the consumer level
Quantity in Commerce 41 units
Distribution Nationwide: including states of AL, CA, FL, CO, GA, KS, LA, MI, MS, NC, OH, TN, TX, and VA
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IOR and Original Applicant = FREEDOM DESIGNS, INC.
-
-