Company:.WalkMed Infusion, LLC.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT WalkMed Infusion Triton Infusion Pump (model 300000). Packaged in a single pump box. Four pump boxes are place in an over-shipper for distribution. Recall Number Z-0369-2016 REASON WalkMed Infusion is conducting a field action on the Triton Infusion Pumps (model numbers 300000 and 400000) because...Read More
Company:.Visicu, Inc.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an...Read More
Company: Philips Medical System12/1610/28Class lI: PRODUCT Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart...Read More
Company: GE Medical Systems, LLC.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the...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.