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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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