Recall Z-0137-2008 ยท IOR Wheelchair, Mechanical
Freedom Designs Inc
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
| Date | Dec 19, 2007 (initiated May 14, 2007) |
| Status | Terminated |
| Reason | Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over. |
| Root cause | 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 | 41 units |
| Distribution | Nationwide: including states of AL, CA, FL, CO, GA, KS, LA, MI, MS, NC, OH, TN, TX, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060926 | TRIPOD Freedom Designs, Inc., May 19, 2006 |