Company: CareFusion 303, Inc. Date of Enforcement Report 2/24/2016 Class lI: PRODUCT An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients....Read More

Company: Bio-Rad Laboratories, Inc.Date of Enforcement Report 2/24/2016 Class lI: PRODUCT EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator’s Manual. In vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays. Recall Number Z-0807-2016 REASON The error...Read More

Company: Varian Medical Systems, Inc. Date of Enforcement Report 2/24/2016 Class lI: PRODUCT Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external...Read More