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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 Recall
IMPAX Cardiovascular (CV) Reporting
see related information
Date Posted August 10, 2012
Recall Status1 Open
Recall Number Z-2184-2012
Recall Event ID 62646
Premarket Notification
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, South Carolina 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
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