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Terminated

IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

FDA Recall Z-0033-2007 · Posted 2006-10-12

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-08-08
Date Terminated2007-02-20
Product Quantity20 Impax 5.2 Mammo licenses were issued domestically.

Reason for Recall

Failed CAD displayed as 'No Findings'

Firm Action

Consignees were notified by letter on/about 08/08/2006.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHOAgfa Corp. · 2002-09-12

Official Source

View FDA Recall →

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

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