Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The s
FDA device recall Z-1241-2008 · posted 2008-06-27 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
- Action taken
- On 6/21-26/2007, AGFA Healthcare notified, via telephone, the affected consignees of the situation. On 7/2/2007, affected consignees were sent, via registered mail, an "Urgent Medical Device Correction" letter instructing them to: a) remove the affected software DICOMstore 2.04.40.00 and replace it with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 43 units
- Distribution
- Worldwide Distributution - USA, including states of AZ, CA, DC, FL, IL, IN, KY, MA, ME, MN, MS, OH, OK, OR, NH, PA, SC, TN, TX, WI, and country of Canada.
- Date initiated
- 2007-06-21
- Date posted
- 2008-06-27
- Date terminated
- 2008-08-04
- Location
- Greenville, SC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |