Company:Mindray DS USA, Inc. dba Mindray North America.Date of Enforcement Report: 7/23/2014 Class lI: PRODUCT V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. Recall Number Z-2059-2014 REASON...Read More

Company:Spacelabs Healthcare IncDate of Enforcement Report: 7/23/2014 Class lI: PRODUCT Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. Recall Number Z-2077-2014 REASON...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 7/23/2014 Class lI: PRODUCT Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of...Read More

Company:Shape Medical Systems, Inc.Date of Enforcement Report: 7/123/2014 Class lI: PRODUCT Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will...Read More