Company: AGFA Corp
Date of Enforcement Report 7/2/2008
Class:ll
PRODUCT
Agfa HeartLab Cardiovascular DICOMstore, Model # L9M8E. The software is used in the Agfa HeartLab Cardiovascular System, Recall # Z-1241-2008
REASON
Misidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by telephone on June 21-26, 2007 and by letter on July 2, 2007.
Manufacturer: Heartlab, Inc., Westerly, RI. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
Nationwide and Canada