Company: Transonic Systems Inc Date of Enforcement Report 9/9/2015 Class lI: PRODUCT Transonic Flow Probes. Product Usage: to measure flow intra-operatively Reacll number 2720-2729. REASON Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69. RECALLING FIRM/MANUFACTURER Transonic Systems Inc, ithaca, NY on 7/27/2015. Voluntary: Firm Initiated...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/9/2015 Class lI: PRODUCT Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report: 9/9/2015 Class lI: PRODUCT Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 9/9/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD — Ortho Clinical Diagnostics Inc. The VITROS 5,1 FS Chemistry System with enGEN(TM)...Read More