Medical Device Recall: Z-0033-2007

FDA Recalls dataset · Firm: AGFA Corp. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-08-08 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0033-2007.

Recall Res Number
Z-0033-2007
Recalling Firm / Manufacturer
FEI Number
3001236302
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-08-08
Date Posted
2006-10-12
Date Terminated
2007-02-20
Product Code
LLZ
Event Number
36203
Product Quantity
20 Impax 5.2 Mammo licenses were issued domestically.
Product Description IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Reason for Recall Failed CAD displayed as 'No Findings'

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

Distribution Pattern Nationwide.

Code Information / Serial Numbers 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.

Related Establishments / Registrations

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

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