Recall Z-1776-2008
Pride Mobility Products Corp · initiated April 11, 2008
Product
Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107
Codes / lots: Serial Numbers: J9602208233020, J5736007315020, J7526107036020, J9629207170020, J7501008030020, J5702908797060, J7529607010020, J9630907149020, J5704608254020, J9603908056020, J9603908056020, J5718007250020, J5723307144020, J5723207301020, J5723407136020, J7227507026020, J5728807092020, J7528907141020, J9629507111020, J7529907223020, J5730907096020, J9632007004020, J9635307146020, J5700308104020, J5726906070020, J5728606106020, J5711407229020, J5711607346020, J5717307078020, J5714307169020, J7219107157020, J5721507327020, J5716207521020, J5716507018020, J5732407100020, J5724107138020, J5725407048020, J5726707458020, J7529907221020, J5732307247020, J5705907063020, J5734507146020, J5735307331020, J5700808254020, J9600908175020, J9602508181020, J9402508170020, J5702508198020, J5702808845020, J5702908207020, J5704608142020, J9601808155020, J7225407065020, J5704208091020, J9622207232020, J9628207076020, J9621407082020, J9626407088020, J9600708204020, J5702508551020, J5710207395020, J9632507088020, J5704608029020, J1133207169020, J9621207095020, J7230507239020, J5727607104020, J9626407085020, J5727707209020, J7527707204020, J5703708169020, J9604408049020, J5730606096020…
Reason for recall
Software - Watch dog timer feature was disabled.
FDA-determined cause: Software design
Action taken
The recalling firm issued an Urgent Device Correction letter on 4/11/08. This letter instructs the dealers to contact the end users so that the units can be upgraded to enable the watch dog feature.
Details
- Recall number
- Z-1776-2008
- Initiated
- April 11, 2008
- Posted by FDA
- August 27, 2008
- Terminated
- November 13, 2009
- Product code
- ITI – Wheelchair, Powered
- Quantity
- 4129
- Distribution
- Class II Recall - Worldwide Distribution --- including USA and Canada.
- Recalling firm
- Pride Mobility Products Corp, Exeter, PA