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Terminated

Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107

FDA Recall Z-1776-2008 · Posted 2008-08-27

Recalling FirmPride Mobility Products Corp
Recall StatusTerminated
Product CodeITI
Date Initiated2008-04-11
Date Terminated2009-11-13
Product Quantity4129

Reason for Recall

Software - Watch dog timer feature was disabled.

Firm Action

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

Distribution Pattern

Class II Recall - Worldwide Distribution --- including USA and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042612JAZZY 600Pride Mobility Products Corp. · 2004-10-06K011993QUANTUM BLASTPride Mobility Products Corp. · 2001-07-13K945936JAZZYPride Health Care, Inc. · 1996-05-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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