Day

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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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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