Company:Varian Medical Systems Oncology SystemsDate of Enforcement Report 10/21/2009 Class:ll PRODUCT Varis, Aria Radiation Oncology – Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the...Read More

Company:Roche Molecular Systems, IncDate of Enforcement Report 10/21/2009 Class:ll PRODUCT AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS...Read More

Company:Cardinal Health Manufacturing, LLC, .Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Pyxis Anesthesia System 3500, The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia...Read More

Company:Neuro Kinetics.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing. Recall # Z-2253-2009 REASON Marketed without a 510k or PMA submission to include the normative data display. RECALLING FIRM/MANUFACTURER Neuro Kinetics, Pittsburgh, PA, by letter on August 10, 2009....Read More

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187084.htm#7Read More

Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Recall # Z-2231-2009 REASON Software Issue/Mistreatment Potential — Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.. RECALLING FIRM/MANUFACTURER Varian...Read More

Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Clinac with Version 7.x Software. Model Numbers: H14, H27 and H29. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. Recall # Z-1729-2009 REASON Unexpected Movement: if the stereotactic...Read More

Company:Brainlab AG.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 – Radiosurgery 3.0 Catalog number 20620 – Radiosurgery 3.5 and Catalog number 20630 – Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and...Read More