Recall Z-0803-05 ยท ITI Wheelchair, Powered
Frank Mobility Systems, Inc.
e-fix E19 power drive. The product is a wheelchair component/accessory.
| Date | May 6, 2005 (initiated Aug 1, 2004) |
| Status | Terminated |
| Reason | may short circuit within the interface due to long term exposure of liquid |
| Root cause | Other |
| Action | The recalling firm issued a Corrective Action Notice to their customers on 9/1/04 via certified mail return receipt. The notice described the problem and the correction (interface was designed). The notice also instructed the dealers/distributors to notify their customers and have the units brought back to them for the exchange. |
| Quantity | 314 units |
| Distribution | The products were shipped to distributors nationwide. The product was also shipped to Mexico and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943789 | POWER WHEELCHAIR CONVERSION KIT Alber Technologies, Inc., Nov 8, 1994 |