November 20, 2013
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Siemens syngo.plaza image processing system image processing radiological system Recall Number Z-0271-2014 REASON The firm became aware of an unintended behavior when using the syngo.plaza. The “Rename” functionality can cause an unintended patient merge if the patient is sent to another...
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Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 Recall Number Z-0281-2014 REASON Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a...
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Company:Philips Healthcare Informatics, Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare...
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Company:Nobel Biocare Usa Llc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery,...
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Company: Hospira Inc Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT ) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with...
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Company: GE Healthcare, LLC Date of Enforcement Report:11/20/2013 Class ll: PRODUCT AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems....
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Company: Carestream Health Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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