Recall Z-2695-2014 ยท IOR Wheelchair, Mechanical
Pdg Product Design Group Inc
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
| Date | Sep 24, 2014 (initiated Jun 12, 2012) |
| Status | Terminated |
| Reason | The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use. |
| Root cause | Component design/selection |
| Action | PDG Product Design group sent all Canadian customers via an e-mail dated August 9, 2012. The letter identified the product the problem and the action needed to be taken by the customer. Immediately call PDG Customer Service @ 1-888-858-4422. Advise the Customer Service Representative that you have received this letter. Our Customer Service Representative will be happy to organize for you to receive a brand new chair. In the United States, we initially notified our Comfort Company who is our only United States Sales Representative. Comfort Company then notified U.S. Consignees via a letter whi |
| Quantity | 153 |
| Distribution | Worldwide Distribution- US Distribution including the states of : AZ, CA, GA, KY, MI, MN, MO, MS, NC, NE, NY, OH, PA, SC, TX, VA, and WA., and Internationally to Canada and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063736 | FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 Pdg Product Design Group, Inc., Jan 17, 2007 |