Company: Varian Medical Systems Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX. The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and...Read More

Company: Varian Medical Systems Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: The 4D Integrated Treatment Console function is...Read More

Company: Bunnell Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 1) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Rx Only. Recall # Z-0901-2011; 2) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Rx Only. Recall # Z-0902-2011 REASON Product software coding error may compromise patient safety. RECALLING FIRM/MANUFACTURER Bunnell, Inc.,...Read More

Company: McKesson Provider Technologies .Date of Enforcement Report 1/19/2011 Class ll: PRODUCT Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and...Read More

Company: GE Healthcare.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 1) HiSpeed LXI (2200997). Recall # Z-0744-2011; 2) HiSpeed LX/l (2200997-2). Recall # Z-0745-2011; 3) HiSpeed DX/I (2201000). Z-0746-2011; 4) HiSpeed DX/I (2201000-2). Recall # Z-0747-2011; 5) HiSpeed DX/I (2249696). Recall # Z-0768-2011; 6) HiSpeed DX/I (2249696-2). Recall # Z-0770-2011; 7) HiSpeed FX/I (2200997 with...Read More

Company: C. R. Bard Inc.Date of Enforcement Report 1/19/2011 Class lll: PRODUCT Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter. Recall # Z-0719-2011 REASON Error can occur...Read More