January 25, 2017
Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Fresenius 2008T Series Hemodialysis System Recall Number Z-1026-2017 through Z-1029-2017 REASON When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled...
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Company:Elekta, Inc.Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-1044-2017 REASON Incorrect dose after editing beam number an wedge angle. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta, GA, on 1/10/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...
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Company: The Binding Site Group, Ltd. Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Digital RID Plate Reader and Software Product Code: AD400 Recall Number Z-1055-2017 REASON If a control ring is marked after reading, the software will not flag results that are out of the specified QC range. RECALLING FIRM/MANUFACTURER The Binding Site Group,...
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Company: Carestream Health Inc Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body Recall Number Z-1052-2017 REASON Software error; Carestream Health Inc, received a complaint stating that when a user...
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Company: Blood Bank Computer Systems, IncDate of Enforcement Report 1/25/2017 Class lI: PRODUCT Blood Bank Control System (BBCS) Primary Application, V 5.4.3, 5.5 is intended to address all phases of donor and transfusion services. The software is also capable of operating with or without ABO QuickPass (BK14130) to allow donors to complete Computer Assisted Self...
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Company: Beckman Coulter Inc. Date of Enforcement Report 1/25/2017 Class lII: PRODUCT AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process....
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Company: DICOM GRID INC Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images. Recall Number Z-1045-2017 REASON A software error caused the window/level to become the same in one series regardless if the image had...
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Company: Carefusion Date of Enforcement Report 1/25/2017 Class I: PRODUCT Product Description: Alaris Syringe Pump Module (Large Volume Pump), Model No. 8100 and AIL sensor kits Recall number Z-0950-2017 REASON CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of...
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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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