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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX CV Reporting NonInvasive Vascular (NIV)/Results Management (RM) NIV

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  Class 2 Device Recall IMPAX CV Reporting NonInvasive Vascular (NIV)/Results Management (RM) NIV see related information
Date Initiated by Firm July 10, 2012
Date Posted July 24, 2012
Recall Status1 Terminated 3 on October 29, 2013
Recall Number Z-2069-2012
Recall Event ID 62534
510(K)Number K050228  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX CV Reporting

The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
Code Information Software Version: RM 2.03 to 2.08, NIV 1.0
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer Reason
for Recall		 When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.
FDA Determined
Cause 2		 Error in labeling
Action AGFA Healthcare sent an Urgent Field Safety Notice dated July 10, 2012, to all affected consignees indicating that a representative from the IMPAX CV product management or professional services team would be contacting them to perform a review of their system. For questions customers were asked to call 401-604-2180. For questions regarding this recall call 864-421-1754.
Quantity in Commerce 6
Distribution Nationwide Distribution including IN, SC, OH, TX
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 = HEARTLAB, INC.
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