FDA Device

IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Hazard

Failed CAD displayed as 'No Findings'

What You Should Do

Remedy

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

Products

IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Brand
AGFA Corp.
UPC
Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433,  Diagnostic Workstation/Impax 5.2/with CAD Capability/CRT: 60+00024432 and  Clinical Review Station/Impax 5.2/with CAD Capability/Flat Panel: 60+00024438. Software version Impax 5.2.2 sites using CAD.

Units Affected

20 Impax 5.2 Mammo licenses were issued domestically.