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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa IMPAX Cardiovascular

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  Class 2 Device Recall Agfa IMPAX Cardiovascular see related information
Date Initiated by Firm December 22, 2016
Create Date June 29, 2017
Recall Status1 Terminated 3 on August 27, 2021
Recall Number Z-2652-2017
Recall Event ID 77629
510(K)Number K050228  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX Cardiovascular
The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
Code Information Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6
Recalling Firm/
AGFA Healthcare Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Cassandra McGowan
Manufacturer Reason
for Recall
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
FDA Determined
Cause 2
Software design
Action AGFA Healthcare sent an Urgent Field Safety Notice dated December 22, 2016, to all affected consignees. The notice included an acknowledgement fax-back or email indicating that the information was received and understood. The notice informed the consignees of the problem and indicated that they would be contacted by Agfa Service to check the problem and to correct the NIV reporting clinical content. Customers with questions were instructed to call 1-401-330-7433. For questions regarding this recall call 864-421-1984.
Quantity in Commerce 10
Distribution Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
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.