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Terminated

Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.

FDA Recall Z-2463-2008 · Posted 2008-09-22

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2006-02-23
Date Terminated2008-11-20
Product Quantity201

Reason for Recall

In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.

Firm Action

Consignees were notified of recall and provided with a software correction patch ICC number 3618.

Root Cause

Software design

Distribution Pattern

Distributed to 106 consignees located throughout the United States and Canada.

Official Source

View FDA Recall →

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

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