July 27, 2016
Company: WalkMed Infusion LLC Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000)The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. Recall Number Z-2219-2016 REASON WalkMed Infusion, LLC Announces a...
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Company: Toshiba America Medical Systems Inc. Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System Recall Number Z-2188-2016 REASON During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images Recall Number Z-2245-2016 REASON Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors....
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 7/27/2016 Class lI: PRODUCT RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 — Radiation Therapy Treatment Planning System — designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions. Recall Number Z-2206-2016 REASON...
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Company: Bayer Healthcare Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to...
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Company: Carestream Health Inc Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 — Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body Recall Number Z-2217-2016 REASON A software issue related to the generic volume measurement...
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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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