February 11, 2015
Company:SCC Soft ComputerDate of Enforcement Report: 2/11/2015 Class lI: PRODUCT SoftLab with SA HIS versions SoftLab is a laboratory information system to be used in a medical research or clinical laboratory. Recall Number Z-1038-2015 REASON The interface fails to send abnormal flags for Reference Lab test results. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL...
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Company:Radiometer America IncDate of Enforcement Report: 2/11/2015 Class lI: PRODUCT ABL90 FLEX analyzer, Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Recall Number Z-1046-2015 REASON The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This...
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Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.) Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of...
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Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment. Recall Number Z-1047-2015 REASON Potential for misinterpretation of...
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Company: Carl Zeiss Meditec AG Date of Enforcement Report 2/11/2015 Class lI: PRODUCT FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928...
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Company: Annimas Corp. Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Recall Number Z-1034-2015 REASON ICalibration factors in the pump overwritten during a programming step. The force sensor...
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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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