Company: Misys Healthcare SystemsDate of Enforcement Report: 4/9/03 Class: II PRODUCT Misys Laboratory, Calculator Data processing Module for Clinical Use. Recall # Z-0678-03. REASON Software anomally. Graphical display omits results containing a less than () or percent (%) symbol. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ., by fax on January 17, 2003....Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 4/9/03 Class: II PRODUCT Misys Laboratory System Version 5.3. Recall # Z-0670-03. REASON Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on February 19, 2003. Firm...Read More

Company: Cti Pet Systems, IncDate of Enforcement Report: 4/9/03 Class: II PRODUCT ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+,ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT...Read More

Company:Beckman Coulter, IncDate of Enforcement Report: 4/9/03 Class: III PRODUCT LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645. Recall # Z-0669-03. CODE REASON Incorrect Hemoglobin result can be reported at software version 2A and higher. All instruments with version 2A or higher. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by telephone and letters...Read More