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U.S. Department of Health and Human Services

Class 3 Device Recall Agfa IMPAX HeartStation ECG Management System

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 Class 3 Recall
Agfa IMPAX HeartStation ECG Management System
see related information
Date Posted November 18, 2009
Recall Status1 Terminated on July 27, 2010
Recall Number Z-0366-2010
Recall Event ID 53604
Premarket Notification
510(K) Number
K050858 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product AGFA IMPAX HeartStation ECG Management System.
Code Information Model number HeartStation 1.1 60+00091179 to 60+0091186; HeartStation Core Server 60+00091211; CV HeartStation EZKT7000, L9NBN000, EZKC000, L9NAL000, EZKWE000 and L9M9G000.
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Jeffery A. Jedlicka
864-421-1815
Manufacturer Reason
for Recall
HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed in the HeartStation Client interface and the report delivered to the consumer. Questions are being directed to the local Agfa representative; the contact information was included in the letter.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action An Urgent Safety Notice was sent via FED-EX to all the sites with the affected units (a total of 6) on May 7, 2009. The three foreign accounts were notified by letter on May 14, 2009. The letter describes the potential issue and mitigation. Acknowledgment via FAX-Back that the information was received and understood was requested from the sites. Customers who use the print, email, fax functionality of this product were verbally notified of the defect and they have been advised of a workaround. In the notice letter, Agfa HealthCare is also providing customers with the recommended workaround. The workaround is to only print from the Viewer screen or to print the ECG once confirmed. The Viewer screen, however, does not allow the user to print batches of reports as does the Index screen. Questions about this matter are being directed to the local Agfa HealthCare representative.
Quantity in Commerce 9 units
Distribution CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
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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