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Company:BioTek Instruments, Inc.Date of Enforcement Report 12/30/2009 Class:ll PRODUCT BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application. Recall # Z-2223-2009 REASON Software design allowed false negatives to be read when wells are dark. RECALLING FIRM/MANUFACTURER...
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Company:GE Medical Systems, LLC.Date of Enforcement Report 12/30/2009 Class:ll PRODUCT Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434. Recall # Z-0002-2009 REASON GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that...
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Company:GE Healthcare Integrated IT Solutions.Date of Enforcement Report 12/16/2009 Class:ll PRODUCT GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-0456-2010 REASON There are potential safety issues, including misdiagnosis or delay in...
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Company:Cyberonics, Inc.Date of Enforcement Report 12/9/2009 Class:ll PRODUCT Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. Recall # Z-0264-2010 REASON Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test...
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Company:Picis, Inc.Date of Enforcement Report 12/9/2009 Class:ll PRODUCT PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. Recall # Z-0365-2010 REASON Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between...
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Company:Baxter Healthcare Renal DivisionDate of Enforcement Report 12/3/2009 Class:ll PRODUCT System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by...
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In the July 2006 IEEE Computer Journal article: “The Power of 10: Rules for Developing Safety- Critical Code” by Gerard J. Holzmann of the NASA/JPL Laboratory for Reliable Software, the following 10 rules were listed: Restrict all code to very simple control flow constructs—do not use go to statements, set jump or long jump constructs,...
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Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 11/25/2009 Class:ll PRODUCT VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Recall # Z-0133-2010 REASON Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will...
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Company:GE Medical Systems Information Tecnology.Date of Enforcement Report 11/18/2009 Class:ll PRODUCT 1) Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1994-2009; 2) Datex-Ohmeda...
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Company:IMTEC IMAGING L.L.C.Date of Enforcement Report 11/12/2009 Class:ll PRODUCT ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in...
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This SoftwareCPR.com newsletter lists items added to the website from March 26, 2009 to November 9, 2009 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and...
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The EU standardization organizations, CEN and CENELEC, have formed a joint working group on standards for software and medical devices (SAMD). The first meeting will be December 8th. Notice is at the link provided. With the harmonization of IEC 62304 (including for IVD devices), potential modifications to the scope of 60601, and the recent Medical...
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The European Commission Borderline and Classification committee has put out a call for software experts to join a working group on qualification and classification of software. The first meeting will be December 2nd, and will be chaired by Lennart Philipson from the Swedish Medical Products Agency. The Medical Information System report from Sweden has been...
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The Carnegie Mellon Software Engineering Institute continued work on safety assurance cases for medical devices by publishing a paper entitled “Towards an Assurance Case Practice for Medical Devices” doing an example case for an infusion pump. The full article is at the link provided. Although this is intended uses infusion pumps as an example it...
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For those using or interested in the SEI’s Capability Maturity Model, the link provided contains a white paper comparing IEC 62304 and the CMMi. This white paper was prepared by David Walker, a consultant that is a licensed SEI partner. It is published here with his permission. 62304-CMMi-comparison-DWalker092909
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This topic includes links to software safety guidance from other safety related industries that have useful information that could be applied to medical device software. All of these and sometimes others are in the document library section of the website.
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/docs/FDATraining-Module7IEC62304-BECSconferencePresentation-JMurray110409.pdf
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/docs/FDA-MDDSpresentation4BECSConference-JMurray110409.pdf
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Sandy Hedberg of SoftwareCPR reported that at the BECS conference Nov. 4-5, 2009 Brian Fitzgerald of FDA gave a presentation in which use of virtual machines was mentioned. Sandy’s synopsis is: Brian Fitzgerald of FDA discussed use of the emerging technology, of virtual machines. A virtual machine is a hardware emulation layer of an operating...
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Health Canada now indicates that patient management software fits the definition of a medical device. “Any patient management software used only for archiving or viewing information or images, and not involved in the primary acquisition, manipulation and transfer of data, is considered a Class I medical device based on Rule 12 of the Medical Devices Regulations.”
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Company:GE Healthcare Integrated IT SolutionDate of Enforcement Report 10/28/2009 Class:ll PRODUCT Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software. The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images. Recall # Z-2316-2009 REASON Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study...
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Company:Neuro Kinetics.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing. Recall # Z-2253-2009 REASON Marketed without a 510k or PMA submission to include the normative data display. RECALLING FIRM/MANUFACTURER Neuro Kinetics, Pittsburgh, PA, by letter on August 10, 2009....
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Company:Cardinal Health Manufacturing, LLC, .Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Pyxis Anesthesia System 3500, The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia...
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Company:Brainlab AG.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 – Radiosurgery 3.0 Catalog number 20620 – Radiosurgery 3.5 and Catalog number 20630 – Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and...
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Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Clinac with Version 7.x Software. Model Numbers: H14, H27 and H29. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. Recall # Z-1729-2009 REASON Unexpected Movement: if the stereotactic...
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Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 10/21/2009 Class:ll PRODUCT Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Recall # Z-2231-2009 REASON Software Issue/Mistreatment Potential — Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.. RECALLING FIRM/MANUFACTURER Varian...
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Company:Varian Medical Systems Oncology SystemsDate of Enforcement Report 10/21/2009 Class:ll PRODUCT Varis, Aria Radiation Oncology – Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the...
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http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187084.htm#7
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Company:Roche Molecular Systems, IncDate of Enforcement Report 10/21/2009 Class:ll PRODUCT AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS...
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Company:Micro Typing Systems, Inc.Date of Enforcement Report 10/14/2009 Class:ll PRODUCT Ortho ProVue, Product Code MTS213784. Recall # B-1268-09 REASON Software, with an anomaly (Versions 2.16 and below) affecting transmission of results from the Ortho ProVue using a bi-directional Laboratory Information System (LIS) interface, was distributed. RECALLING FIRM/MANUFACTURER Recalling Firm: Micro Typing Systems, Inc., Pompano Beach,...
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Company:AGFA Corp.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa’s Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. Recall # Z-1889-2009 REASON After opening and closing a study on a Central Monitoring System while...
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Company:Hologic Inc.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT 1) Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body...
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Company:Toshiba Medical Systems Co.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Recall # Z-0005-2009 REASON Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in...
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Company:Carl Zeiss Meditec Inc.Date of Enforcement Report 10/7/2009 Class:ll PRODUCT Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of...
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CDRH moved to a new location. The address of the document mail center for submissions and related communications is now: U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
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Company:Hitachi Medical Systems America Inc., .Date of Enforcement Report 9/30/2009 Class:ll PRODUCT 1) EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Recall # Z-2054-2009; 2) EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and...
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Company:Perkin Elmer.Date of Enforcement Report 9/30/2009 Class:ll PRODUCT a) Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results. Recall # Z-1905-2009; b) Specimen Gate Lab – MSMS Data Suite,...
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“IEC TR 80002-1 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software” has been released. This standard was based on AAMI TIR32 but focuses on the 14971 perspective. AAMI has adopted TR 80002-1 as well and may obsolete TIR32 although there are some areas where TIR32 is...
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Company:American Optisurgical Inc.Date of Enforcement Report 9/16/2009 Class:ll PRODUCT American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery. Recall # Z-1808-2009 REASON Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead...
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Company:Hospira Inc.Date of Enforcement Report 9/2/2009 Class:ll PRODUCT 1) Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1815-2009; 2) Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1816-2009 REASON Potential delay/under infusion of critical therapy–...
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Company:Veridex, LLCDate of Enforcement Report 8/26/2009 Class:ll PRODUCT CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater, Recall # Z-1734-2009 REASON Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System. RECALLING FIRM/MANUFACTURER Veridex, LLC, Raritan, NJ, by letter dated March 12,...
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Company: Cardinal HealthDate of Enforcement Report 8/26/2009 Class:l PRODUCT 1) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above, Recall # Z-1790-2009; 2) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the...
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Company:GE Medical Systems, LLCDate of Enforcement Report 8/26/2009 Class:ll PRODUCT GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images, Recall # Z-1720-2009 REASON...
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Company: Hitachi Medical Corporation.Date of Enforcement Report 8/5/2009 Class:ll PRODUCT 1) Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less, Recall # Z-1651-2009; 2) Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version 2.11 or less, Recall # Z-1652-2009 REASON Incorrect scale on image: A software error can occur if two (2) different Field-of-View...
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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

Next public offering:  June 24-26, 2025 (Boston, MA)

Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person.  These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.

 

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

 


 

Being Agile & Yet Compliant (Public)

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

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

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • Americas: 11-13 February 2025
  • EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
  • Southern Central Northeastern Pacific: 24-26 February 2025
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

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)

Next public offering:  TBD

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