Company:RAYSEARCH Laboratories AB,. Date of Enforcement Report 4/11/12 Class ll: PRODUCT RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. Model RayStation 2.0. Designed for treatment planning and analysis of radiation therapy. Recall # Z-1317-2012 REASON An issue was found with the dose calculation, that could result in a potential overestimation of the dose. This could...Read More

Company:Medtronic Neuromodulation Date of Enforcement Report 4/11/12 Class ll: PRODUCT Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N’Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system contains and administers...Read More

/Docs/FDA-513gFinalGuidance040612.pdfRead More

Company:Philips Medical Systems Date of Enforcement Report 4/11/12 Class ll: PRODUCT Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model # 728231, Ingenuity CT Model # 728326. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission...Read More