Company:Varian Medical Systems, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall # Z-1175-2012 REASON An...Read More
Company:Siemens Healthcare Diagnostics, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT Siemens Healthcare Diagnotics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension...Read More
Company:Safe Trace Tx (Horizon Blood Bank, Haemonetics Software SolutionsDate of Enforcement Report 5/30/12 Class ll: PRODUCT SafeTrace Tx, also rebranded as Horizon Blood Bank Haemonetics Software Solutions (formerly Wyndgate Technologies) Recall # B-1434-12 REASON Safe Trace Tx (Horizon Blood Bank, Haemonetics Software Solutions), with a software glitch or defect that could result in an ABO...Read More
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT ACUSON S1000 ultrasound systems running software version 1.0. The product is indicated for use as an ultrasound imaging system. Recall # Z-1616-2012 REASON When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the...Read More
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