Company: Varian Medical Systems, IncDate of Enforcement Report: 3/26/03 Class: II PRODUCT VARiS 1.4G and Vision/Soma Vision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x. Recall # Z-0633*03. REASON The product has a software problem. This could result in a treatment without a motorized wedge where one had...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0614-03. CODE Versions 5.2, 5.23 and 5.3. REASON Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0647-03. REASON Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface. CODE Version 5.3 with Reference Laboratory Interface. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Tucson, AZ, by facsimile on October 18, 2002. Firm...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0626-03. REASON Software anomaly. Patient results may be filed in the incorrect patient file. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing. VOLUME...Read More