Company: Ortho-Clinical Diagnostics Date of Enforcement Report 4/30/2014 Class lI: PRODUCT VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II...Read More

Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report 4/30/2014 Class lI: PRODUCT RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. Recall Number Z-1481-2014 REASON RaySearch Laboratories has recalled “RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0” software due to dose miscalculations for bolus/external/fixation support structures...Read More

Company:Ion Beam Applications S.A Date of Enforcement Report 4/30/2014 Class lI: PRODUCT Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy Recall Number Z-1492-2014 REASON Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/30/2014 Class lI: PRODUCT Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 4/30/2014 Class lI: PRODUCT iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. Recall Number Z-1487-2014 REASON Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to...Read More