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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 Recall
Agfa Heartlab Cardiovascular Results Management Product
see related information
Date Posted June 27, 2008
Recall Status1 Terminated on October 10, 2008
Recall Number Z-1242-2008
Recall Event ID 46382
Premarket Notification
510(K) Number
K050228 
Product Classification System, Image Processing, Radiological - 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, South Carolina 29601-2632
Consumer Instructions Contact the recalling firm for information
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.
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 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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