Company: Zoll Medical Date of Enforcement Report 7/2/2008 Class:ll PRODUCT Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher, Recall # Z-1167-2008 REASON Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or...Read More

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,...Read More