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U.S. Department of Health and Human Services

Class 2 Device Recall AdminTool2

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 Class 2 Recall
see related information
Date Posted November 23, 2011
Recall Status1 Terminated on June 26, 2012
Recall Number Z-0272-2012
Recall Event ID 60164
Premarket Notification
510(K) Number
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting.
Code Information Software Versions 1.00.26, 1.00.27, CV7.4.SU3 and CV7.8.
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Debbie Norris
Manufacturer Reason
for Recall
Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.
FDA Determined
Cause 2
DESIGN: Software Design
Action An 'URGENT FIELD SAFETY NOTICE" was sent via FED-EX by June 6, 2011 to all the sites using the affected product. The letter described the issue and mitigation. The letter recommends that users not move reports to studies where a report already exists. If a report is being moved because the existing report is irrelevant to the study, then the existing report should be deleted prior to moving the new report to that study. If the report is being moved because the user wants to combine the content of the reports, then the "merge" function should be utilized. The letter also states that a software enhancement is currently available. Acknowledgment via FAX-Back was requested from the sites. Questions regarding the issue should be directed to customers' local Agfa HealthCare Service at 877-777-2432. The firm has identified 185 additional sites and an "URGENT FIELD SAFETY NOTICE" was sent on October 12, 2012.
Quantity in Commerce 323 units
Distribution Worldwide Distribution -- USA, Virgin Islands 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.