Company: Merge Healthcare, Inc. Date of Enforcement Report 12/28/2016 Class lI: PRODUCT Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recall Number Z-0878-2017 REASON Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis...Read More
Company: Radiometer America Inc.Date of Enforcement Report 12/28/2016 Class lI: PRODUCT AQURE System Software Version 2.2.0Model #: 933-599UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor...Read More
Company: Medtronic Neuromodulation Date of Enforcement Report 12/28/2016 Class lI: PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable...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 firstname.lastname@example.org for more info.