Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with T
FDA device recall Z-0137-2008 · posted 2007-12-19 · Terminated
Recall details
- Recalling firm
- Freedom Designs Inc
- Reason for recall
- Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.
- Action taken
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 41 units
- Distribution
- Nationwide: including states of AL, CA, FL, CO, GA, KS, LA, MI, MS, NC, OH, TN, TX, and VA
- Date initiated
- 2007-05-14
- Date posted
- 2007-12-19
- Date terminated
- 2008-07-14
- Location
- Simi Valley, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIPOD (K060926) | Freedom Designs, Inc. | 2006-05-19 |