Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
- Company
- Agfa Corp.
- Recall Initiated
- June 21, 2007
- Posted
- June 27, 2008
- Terminated
- August 4, 2008
- Recall Number
- Z-1241-2008
- Quantity
- 43 units
- Firm Location
- Greenville, SC
Reason for Recall
MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
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.
Lot / Code Info
DICOMstore, L9M8E, Software version: 2.04.40.00
Root Cause
Software design
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.