Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0804-05

e-fix E20 power drive. The product is a wheelchair component/accessory

Frank Mobility Systems, Inc. / initiated 2004-08-01 / Terminated

Frank Mobility Systems, Inc. began a recall of e-fix E20 power drive. The product is a wheelchair component/accessory on . The reason FDA records is "may short circuit within the interface due to long term exposure of liquid". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0804-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Frank Mobility Systems, Inc.
Product
e-fix E20 power drive. The product is a wheelchair component/accessory.
Product code
ITI Wheelchair, Powered
Reason for recall
may short circuit within the interface due to long term exposure of liquid
FDA 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 in commerce
314 units
Distribution
The products were shipped to distributors nationwide. The product was also shipped to Mexico and Panama.
Product codes and lots
model number E20