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Terminated

Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891

FDA Recall Z-1242-2008 · Posted 2008-06-27

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-07-27
Date Terminated2008-10-10
Product Quantity6 units

Reason for Recall

Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution -- USA including states of GA, NH, NY and TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050228AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc. · 2005-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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