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U.S. Department of Health and Human Services

Class 2 Device Recall Results Management (RM) Reporting Module

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  Class 2 Device Recall Results Management (RM) Reporting Module see related information
Date Initiated by Firm June 06, 2011
Date Posted November 18, 2011
Recall Status1 Terminated 3 on July 02, 2013
Recall Number Z-0211-2012
Recall Event ID 60154
510(K)Number K050228  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX Cardiovascular Results Management (RM) Software Versions RM to RM 7.8 SU2

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: RM2.04.37.04 to RM 7.8 SU2 (RM is a version prior to CV 7.2 release).
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Norris
Manufacturer Reason
for Recall
Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.
FDA Determined
Cause 2
Software design
Action AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 27, 2011, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to carry out a merge post finalization of an RM reports. If it is necessary to modify a finalized report, AGFA recommends that they make the modification through one of the following actions: Amend the report through the RM interface, or Call AGFA Service to change the status of the report to "preliminary" and then proceed with the finalization of the report. AGFA issued an Acknowledgment, via FAX- Back that the information was received and understood to affected customers. For any questions customers were instructed to contact their AGFA Healthcare Service at 877-777-2432.
Quantity in Commerce 323
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.