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.
This recall has been terminated (originally issued June 27, 2008).
- 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
- Official Source
- View on FDA website ↗
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.