Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island
FDA device recall Z-1242-2008 · posted 2008-06-27 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
- Action taken
- 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
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 6 units
- Distribution
- Nationwide Distribution -- USA including states of GA, NH, NY and TX
- Date initiated
- 2007-07-27
- Date posted
- 2008-06-27
- Date terminated
- 2008-10-10
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |