Day

September 28, 2016
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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.