Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/30/2015 Class lI: PRODUCT ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 9/30/2015 Class lI: PRODUCT MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST). Recall Number Z-2809-2015 REASON Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the...Read More