Date Initiated by Firm |
February 22, 2008 |
Date Posted |
March 31, 2008 |
Recall Status1 |
Terminated 3 on July 27, 2010 |
Recall Number |
Z-1349-2008 |
Recall Event ID |
46889 |
510(K)Number |
K050228
|
Product Classification |
PAC System/Report Management - 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 SC 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 |
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
|
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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.
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