AGFA Corp. IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Brand
AGFA Corp.
Lot Codes / Batch Numbers
Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433
Products Sold
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.
AGFA Corp. is recalling IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) due to Failed CAD displayed as 'No Findings'. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed CAD displayed as 'No Findings'
Recommended Action
Per FDA guidance
Consignees were notified by letter on/about 08/08/2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026