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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX

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  Class 2 Device Recall IMPAX see related information
Date Initiated by Firm August 08, 2006
Date Posted October 12, 2006
Recall Status1 Terminated 3 on February 20, 2007
Recall Number Z-0033-2007
Recall Event ID 36203
510(K)Number K022292  
Product Classification mammography - Product Code LLZ
Product IMPAX¿ 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Code Information 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.
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
864-828-1827
Manufacturer Reason
for Recall		 Failed CAD displayed as 'No Findings'
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on/about 08/08/2006.
Quantity in Commerce 20 Impax 5.2 Mammo licenses were issued domestically.
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA CORP.
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