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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa Heartlab Cardiovascular Results Management Product

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  Class 2 Device Recall Agfa Heartlab Cardiovascular Results Management Product see related information
Date Initiated by Firm July 27, 2007
Date Posted June 27, 2008
Recall Status1 Terminated 3 on October 10, 2008
Recall Number Z-1242-2008
Recall Event ID 46382
510(K)Number K050228  
Product Classification Electrocardiogram (ECG) System - Product Code LLZ
Product Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
Code Information Results Management Model Number: L58RZ and L9MWQ, Version 2.03 and 2.04
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		 Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
FDA Determined
Cause 2		 Software design
Action On 7/27/2007 to 8/16/2007, AGFA Healthcare notified, via telephone, consignees of the situation. On 7/27/2007, a formal customer notification letter was sent to affected consignees, providing them with a respective listing of patients that were potentially affected. AGFA informed the consignees that the firm would correct any incorrect patient ECG data. AGFA also informed their consignees that they would provide a configuration update to correct the problem. A notification confirmation form to be return to the firm was also attached to the notification letter, which also provided the firm's customer service number: (877) 777-2432.
Quantity in Commerce 6 units
Distribution Nationwide Distribution -- USA including states of GA, NH, NY and TX
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.
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