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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX Cardiovascular (CV) Reporting

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  Class 2 Device Recall IMPAX Cardiovascular (CV) Reporting see related information
Date Initiated by Firm July 27, 2012
Date Posted August 10, 2012
Recall Status1 Terminated 3 on January 13, 2015
Recall Number Z-2184-2012
Recall Event ID 62646
510(K)Number K050228  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX Cardiovascular (CV) Reporting

Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Code Information Model # L9M2100 - All Software versions of IMPAX CV Reporting
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		 Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
FDA Determined
Cause 2		 Software change control
Action AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE dated July 27, 2012, to all affected customers. The letter described the safety alert and mitigation. Customer were asked to complete the Acknowledgment form and fax back to 864-421-1664 that the information was received and understood. For questions customers were instructed tol call 401-604-2180. For questions regarding this recall call 864-421-1754.
Quantity in Commerce 280
Distribution Worldwide Distribution - USA (nationwide) and Canada
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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