Company: Sunquest Information systems, aka Misys HealthcareDate of Enforcement Report: 5/1/02 Class: II PRODUCT Misys Laboratory Microbiology Module, Recall # Z-0916-2. REASON Software does not allow comments to be shown in some reports. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information systems, aka Misys Healthcare, Tucson, AZ. Firm initiated recall is ongoing. VOLUME...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 5/1/02 Class: II PRODUCT All DataCare Systems Software, as follows: Recall # Z-0960-2/Z-0974-2. a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200; b) DataCare ABG Data Management System for use in a blood gas point of care testing...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 5/1/2002 Class: III PRODUCT Integris H5000, Angiographic X-ray system. Recall # Z-0924-2. REASON System may occasionally re-boot during a patient examination. CODE Units with SYSCO software version 11.1.2. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated November 14, 2001., Manufacturer: Philips...Read More

Company: Hitachi LtdDate of Enforcement Report: 5/1/02 Class: II PRODUCT Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961. Recall # Z-0922-2. REASON Possibility of false negative and false positive results being reported. CODE All units with software version 01-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter...Read More