Company: Spacelabs Medical, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Recall # Z-1395-2/Z-1401-2. a) Telemetry Digital Processors Models 90342, 90344, 90346, 90348. Recall # Z-1395-2/Z-1398-2; b) Integrated Multiparameter Module Model 90470. Recall # Z-1399-2; c) Telemetry Receiver Module Model 90478. Recall # Z-1400-2; d) Ultarview Command Module Model 90496. Recall # Z-1401-2. REASON ECG...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Misys laboratory version 5.3 with custom Result Interface 11. Recall # Z-1405-2. REASON Software anomaly causing mixing of patient data. CODE Version 5.3 with custom Result Interface 11. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax on June 13, 2002. Firm...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Misys Laboratory. Recall # Z-0002-3. REASON Software anomaly. Quality assurance flags were not appearing as they should on cumulative reports. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002. Firm initiated recall is...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Cytomics RXP software. Recall # Z-1387-2. REASON When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if “% in Regions” is selected. CODE Version 1.0. RECALLING FIRM/MANUFACTURER Beckman Coulter Inc., Brea, CA, by letters dated May 15,...Read More