Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/30/03 Class: II PRODUCT Magic View 1000U, version VE40A. Digital Image Communication System. Recall # Z-1029-03. REASON Software issue. New examinations may not be saved properly and the examination may be lost. CODE Part number 7502003. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA, by...Read More

Company: Roche Diagnostics, CorpDate of Enforcement Report: 7/30/03 Class: II PRODUCT MagNA Pure LC Instrument; Catalog number 2236931. Recall # Z-1001-03. REASON Potential for false negative patient results with software version 3.0. CODE All units with software version 3.0. RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN, by letter dated May 27, 2003. Firm initiated recall...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 7/30/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1007-03. REASON Software anomally. Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal disignations. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax...Read More