Company: Misys Healthcare SystemsDate of Enforcement Report: 8/20/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1090-03. REASON Software anomaly allows patient reports to contain incomplete data used for Anatomic Pathology Module. CODE Version 5.3 and up to 5.3.2 with Anatomic Pathology Module. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on June 16,...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 8/20/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1092-03. REASON Patient files become mixed up due to a software defect. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare System, Tucson, AZ, by fax on July 2, 2003. Firm initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 1....Read More

Company: Alcon Laboratories, IncDate of Enforcement Report: 8/20/03 Class: II PRODUCT “Alcon Ladarwave Custom Cornea Wavefront System” Aberrometer software Version 7.91. Recall # Z-1078-03. REASON Software error could, under specific circumstances, allow the patient’s centration images and data to be stored incorrectly. CODE Serial Numbers: LWN1002Z LWN1003Z LWN1010Z LWN1011Z LWN1013Z LWN1023Z LWN1025Z LWN1035Z LWN1040Z LWN1440Z...Read More