Company: Siemens Medical SolutionsDate of Enforcement Report 3/30/2011 Class ll: PRODUCT V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at. Multipurpose mobile software controlled diagnostic ultrasound system and on-screen display for thermal and mechanical indices related to bio-effect mechanisms. Its function is to acquire primary...Read More

Company: Toshiba American Medical Systems Inc.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT SSH-880CV Aplio Artida; System, Diagnostic Ultrasound. Recall # Z-1498-2011 REASON Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues. RECALLING FIRM/MANUFACTURER Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA,...Read More

Company: AGFA Corp.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting. Recall # Z-1434-2011 REASON Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: Elekta, Inc.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Recall # Z-1723-2011 REASON If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro...Read More

Company: Baxter Healthcare Corp.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT 1) AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Recall # Z-1383-2011; 2) AUTOMIX Plus High Speed Compounder...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is...Read More

Company: AMO Manufacturing USA, LLC,Date of Enforcement Report 3/30/2011 Class ll: PRODUCT AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664, 0070-1649, 0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 International version. The WaveScan WaveFront System is a class III accessory...Read More