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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 Recall
Results Management (RM) Reporting Module
see related information
Date Posted November 18, 2011
Recall Status1 Terminated on July 02, 2013
Recall Number Z-0211-2012
Recall Event ID 60154
Premarket Notification
510(K) Number
K050228 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 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 2.04.37.04 is a version prior to CV 7.2 release).
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Debbie Norris
864-421-1754
Manufacturer Reason
for Recall
Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.
FDA Determined
Cause 2
DESIGN: 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 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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