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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa IMPAX CardioVascular Suite Results Management

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 Class 2 Recall
Agfa IMPAX CardioVascular Suite Results Management
see related information
Date Posted March 31, 2008
Recall Status1 Terminated on July 27, 2010
Recall Number Z-1349-2008
Recall Event ID 46889
Premarket Notification
510(K) Number
K050228 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI
Code Information Software Versions: 2.04.17, 2.04.19 and 2.04.20.
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
864-421-1815
Manufacturer Reason
for Recall
Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.
FDA Determined
Cause 2
DESIGN: Software Design
Action All five (5) sites utilizing this product were notified about the issue directly via telephone. An "Urgent Safety Notice" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue.
Quantity in Commerce 5 units
Distribution Nationwide to five hospitals in DC, NY, OH, TN, and VA.
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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