Company: Varian Medical Systems Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; 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 radiation therapy from...Read More

Company: Roche Diagnostics Corp/Hitachi LTDDate of Enforcement Report 11/5/2008 Class:ll PRODUCT Roche/Hitachi Modular E Module immunoassay analyzer, GMMI Nos. 04998642001 and 03617505001, Recalling Firm: Z-0165-2009 REASON A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter...Read More

Company: Philips Medical SystemsDate of Enforcement Report 11/5/2008 Class:ll PRODUCT M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient, Recall # Z-0100-2009...Read More

Company: Philips Healthcare Informatics, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital...Read More

Company: Draeger Medical, IncDate of Enforcement Report 11/5/2008 Class:ll PRODUCT Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300, Recall # Z-0202-2009 REASON May experience an interruption of ventilation for approximately 5 seconds. RECALLING FIRM/MANUFACTURER Recalling Firm: Draeger Medical, Inc., Telford, Pa, by letter dated September 2008. Manufacturer:...Read More

Company: Philips Healthcare Informatics, Inc., Date of Enforcement Report 11/5/2008 Class:ll PRODUCT iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device...Read More

Company: Hill-Rom Manufacturing, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Envision E700 Low Airloss Therapy Surface. The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4’11” and 6′ 4″ in height, Recall...Read More

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 11/5/2008 Class:ll PRODUCT Centricity Perinatal (formerly Quantitative Sentinel) System – Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit, Recall # Z-0112-2009 REASON On the I&O chart, the IN, OUT...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02 ultrasound system with onscreen display, Recall # Z-0086-2009 REASON Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Acuson X300 ultrasound systems, ultrasound system with onscreen display. Model numbers 10037409, 10038837, 10348531. Potentially affected, but no volume currently: 10132987, 10133170, 10348532, 10348533, Recall # Z-0111-2009 REASON Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the...Read More