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U.S. Department of Health and Human Services

Class 2 Device Recall CRS

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 Class 2 Recall
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Date Posted February 24, 2011
Recall Status1 Terminated on March 29, 2011
Recall Number Z-1434-2011
Recall Event ID 57821
Premarket Notification
510(K) Number
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.
Code Information Software Versions 2.12.05 - 2.14.03.SU1
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Jeffery A. Jedlicka
Manufacturer Reason
for Recall
Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.
FDA Determined
Cause 2
Action The firm, AGFA Healthcare, sent a "Safety Notice" dated January 27, 2011 to all customers. The notice described the product, problem and action to be taken by firm and customer. AGFA informed the customers that a software upgrade was made between December 2008 and February 2010 and instructed the customers to distribute this information to all individuals within their facility and to complete and return the attached URGENT SAFETY NOTICE FEEDBACK FORM via fax to 864-421-1664 or email to debbie.norris@agfa.com. Note: Service Bulletin DD+DIS100.09E, was issued March 2009 and an upgrade from Software Versions 2.12.05 through 2.14.03.SU1 to Software Version CRS 2.14.03.SU2 was required for the impacted sites. Most identified consignees/customers required the software upgrade, but some consignees/customers had already been upgraded prior to the event and did not require additional upgrades. If you have any questions about this matter, please contact the Post Market/QARA North America via email at debbie.norris@agfa.com or call at 864-421-1754.
Quantity in Commerce 107
Distribution Worldwide distribution: USA and country of: 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.