Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images Recall Number Z-2852-2016 REASON Software error. Incorrect values for the volume calculation from a freehand VOI at...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-2853-2016 REASON Software error. Incorrect values for the volume calculation from a freehand VOI...Read More

Company:Invivo Corporation Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.. Recall Number Z-2790-2016 REASON Frozen...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 9/28/2016 Class lI: PRODUCT CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. Recall Number Z-2871-2016 REASON An incorrect...Read More