Atlas FDA

Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610,

FDA device recall Z-1776-2008 · posted 2008-08-27 · Terminated

Recall details

Recalling firm
Pride Mobility Products Corp
Reason for recall
Software - Watch dog timer feature was disabled.
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.
Root cause
Software design
Status
Terminated
Product code
ITI
Quantity affected
4129
Distribution
Class II Recall - Worldwide Distribution --- including USA and Canada.
Date initiated
2008-04-11
Date posted
2008-08-27
Date terminated
2009-11-13
Location
Exeter, PA

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Related 510(k) clearances

RecordFirmDate
JAZZY 600 (K042612)Pride Mobility Products Corp.2004-10-06
QUANTUM BLAST (K011993)Pride Mobility Products Corp.2001-07-13
JAZZY (K945936)Pride Health Care, Inc.1996-05-28