April 29, 2020
Company: Radiometer Medical ApS Date of Enforcement Report: 4/29/2020 Class II PRODUCT TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) – Product Usage: It is indicated for use on pediatrics and adults. Recall Number: Z-1755-2020 REASON Reports have...
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Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report: 4/29/2020 Class II PRODUCT Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX;...
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Company: Philips North America, LLC Date of Enforcement Report: 4/29/2020 Class II PRODUCT TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861 Recall Number: Z-1766-2020 REASON The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed...
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Company: Synaptive Medical Inc. Date of Enforcement Report: 4/29/2020 Class II PRODUCT ClearCanvas RIS/PACS Recall Number: Z-1758-2020 REASON A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. RECALLING FIRM/MANUFACTURER Synaptive Medical Inc. on 2/26/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 4/29/2020 Class II PRODUCT Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352. Recall Number: Z-1741-2020 REASON Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused...
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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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