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DATES:  February 4-6, 2020 COST: 3 Full Days for $2,595.00 (Registration closes 1/14/2020) Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! Volume Discount:  $450 off for multiple students from same company Register Now:  https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 This three-day course provides a clear understanding of the 62304 standard for medical device software, FDA...
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This new draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., CDER-led combination product) and the device portion has electronics and/or software that is planned to be used as a platform, that is,...
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A probe into a series of engine failures on Airbus’s smallest jet, the A220, is studying whether a software change set off unexpected vibrations that damaged fast-moving parts and forced three emergency landings. Investigators are focusing their attention on recent changes in engine software that may have caused parts that compress air inside the engine...
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Registration for our 62304 and Emerging Standards software course February 4-6, 2020, in Sunnyvale, CA is in full swing!  Onward to higher software quality – keep pressing forward!
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Company: Abbott Laboratories, Inc Date of Enforcement Report: 10/16/2019 Class II PRODUCT Alinity S System, Part Number 06P16-01 Recall Number: Z-0111-2020 REASON Two software issues have been identified for the Alinity S System containing software version 2.0.0: Alinity’s Probe Wash: When Alinity’s CMV IgG Qualitative assay is run as the last assay on a sample,...
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One of the first steps on the marketing pathway for a medical device is to classify your device. As technology and innovation continue to advance, determining how to classify a device can be complex and challenging. This session will provide information on interacting with FDA for device determination and an introduction to Section 513(g) Requests...
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The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Denterprise International, Inc., 100 E. Granada Blvd. Ste. 219, Ormond Beach, Florida, from May 1, 2019 to May 6, 2019. During the inspection, an FDA investigator determined that your firm is a specifications developer, manufacturer of the...
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Company: WOM World of Medicine AG Date of Enforcement Report: 10/9/2019 Class II PRODUCT Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. Recall Number: Z-2767-2019 REASON The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk....
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Company: ELITech Group B.V. Date of Enforcement Report: 10/9/2019 Class III PRODUCT Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 – Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been...
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Company: Elekta Inc Date of Enforcement Report: 10/2/2019 Class II PRODUCT Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and...
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Company: GE Healthcare, LLC Date of Enforcement Report: 10/2/2019 Class II PRODUCT Proteus XR/a (SlOK : K993090) Recall Number: Z-2449-2019 REASON Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC on 8/9/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Vital Scientific N.V. Date of Enforcement Report: 10/2/2019 Class II PRODUCT V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of...
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Company: Roche Diabetes Care, Inc. Date of Enforcement Report: 10/2/2019 Class II PRODUCT Accu-Chek Connect Diabetes Management App Recall Number: Z-2753-2019 REASON Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. RECALLING FIRM/MANUFACTURER Roche Diabetes Care, Inc. on 5/3/2019. Voluntary:  Firm Initiated recall is...
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 10/2/2019 Class II PRODUCT Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.5, V1.5.1;...
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URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware...
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August and September 2019 continued a busy trend of regulatory and compliance activity – there were 42 software related recalls!  We also announced our 2020 Public Training Course dates!  Onward to higher software quality – keep pressing forward!
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Brian Pate has created this job aid to assist with explaining the separation of design input from the design process.  The diagram illustrates the "flow down" process of high level, intended use functionality traces downward to more detailed requirements and specifications.  Where do we draw the line with design input?  What should be the focus...
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The U.S. Food and Drug Administration released a suite of “Digital Health” guidances. The guidances issued today are a continuation of the Agencies efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act. The first guidance announced is Clinical Decision Support Software, a revised...
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The 2015 Amendment 1 update to IEC 62304 added a new clause that requires identification of “categories of defects associated with the selected programming technology” and providing analysis and other evidence demonstrating “that these defects do not contribute to unacceptable risk.”  Read a recent article on challenges with using C language.
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Company: CareFusion 303, Inc. Date of Enforcement Report: 9/11/2019 Class II PRODUCT Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 Recall Number: Z-2443-2019 REASON Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 RECALLING FIRM/MANUFACTURER CareFusion 303, Inc....
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Company: SonarMed Inc Date of Enforcement Report: 9/11/2019 Class II PRODUCT SonarMed AirWave Monitor, Model Number M0001 Recall Number: Z-2450-2019 REASON Potential for the presence of two error codes which would make the monitor inoperable. RECALLING FIRM/MANUFACTURER SonarMed Inc. on 4/17/2017. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 16 units DISTRIBUTION...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 9/11/2019 Class II PRODUCT syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603 Recall Number: Z-2440-2019 REASON SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT...
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Company: Becton Dickinson & Co. Date of Enforcement Report: 9/11/2019 Class II PRODUCT BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202 Recall Number: Z-2438-2019 Recall Number: Z-2439-2019 REASON An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate....
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Company: Elekta, Inc. Date of Enforcement Report: 9/4/2019 Class II PRODUCT Monaco Radiation Treatment Planning System (RTP) System Recall Number: Z-2409-2019 REASON Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions. RECALLING FIRM/MANUFACTURER Elekta, Inc. on 8/23/2019. Voluntary: ...
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Company: Phadia Ab Date of Enforcement Report: 9/4/2019 Class II PRODUCT Phadia” 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results. Recall Number: Z-2397-2019 REASON Code 7-102 Liquid...
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Company: Spectrum Medical Ltd. Date of Enforcement Report: 9/4/2019 Class I PRODUCT Quantum Pump Console Recall Number: Z-2238-2019 REASON Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. RECALLING FIRM/MANUFACTURER Spectrum Medical Ltd. on 5/29/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 9/4/2019 Class II PRODUCT Alinity ci -series System Control Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes...
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Company: Agilent Technologies, Inc. Date of Enforcement Report: 9/4/2019 Class II PRODUCT MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by...
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Company: Qiagen Sciences LLC Date of Enforcement Report: 8/28/2019 Class II PRODUCT QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 8/28/2019 Class II PRODUCT ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver),...
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Company: Radiometer America Inc Date of Enforcement Report: 8/28/2019 Class II PRODUCT ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Recall Number: Z-2320-2019 REASON Software Security; The action is being initiated because of software security vulnerabilities with the firm’s analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment. RECALLING...
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Company: Luminex Corporation Date of Enforcement Report: 8/28/2019 Class II PRODUCT Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017. Recall Number: Z-2292-2019 REASON An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners...
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Today, the German Federal Institute for Drugs and Medical Devices (BfArM) identified critical vulnerabilities in the Wind River VxWorks real-time operating system. Affected versions of VxWorks are: VxWorks 6.5 to 6.9 (End-of-Life) VxWorks 7 (SR540 and SR610) VxWorks 653 MCE 3.x (may be affected) They pointed out that VxWorks is used in many medical devices....
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/21/2019 Class II PRODUCT SOMATOM Definition AS, Model Number 8098027 – Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician...
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Company: Fenwal Inc Date of Enforcement Report: 8/21/2019 Class II PRODUCT VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults,...
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Company: Fenwal Inc Date of Enforcement Report: 8/21/2019 Class I PRODUCT VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults,...
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The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered. One critical way to help ensure product quality is to prevent data integrity lapses from the outset. Over the...
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Company: Philips North America, LLC Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Lantis 6.1 Commander, Model # 5493072 – Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Ingenuity CT, Model # 728326, computed tomography x-ray system Recall Number: Z-2186-2019 Ingenuity Core128 Model # 728323, computed tomography x-ray system Recall Number: Z-2187-2019 Ingenuity Core Model # 728321, computed tomography x-ray system Recall Number: Z-2188-2019 iCT, Model # 728306, computed...
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Company: Ortho Clinical Diagnostics Date of Enforcement Report: 8/14/2019 Class II PRODUCT VITROS 250 Chemistry System, clinical chemistry analyzer Recall Number: Z-2174-2019 Recall Number: Z-2175-2019 VITROS 250AT Chemistry System, clinical chemistry analyzer Recall Number: Z-2176-2019 VITROS 350 Chemistry System, clinical chemistry analyzer Recall Number: Z-2177-2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ...
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Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 8/14/2019 Class II PRODUCT The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,”* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a...
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Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT ORTHO VISION Analyzer for ID-MTS Gel Cards (ORTHO VISION), Software Version 5.12.3 and 5.12.4, Product Code: 6904577 Recall Number: B-0800-2019 ORTHO VISION Max Analyzer for ID-MTS Gel Cards (ORTHO VISION Max), Software Version 5.12.3 and 5.12.4, Product Code: 6904576 B-0801-2019 REASON Ortho...
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The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, TALON, an S&S Technology Company, located in Houston, TX, from March 11 – 28, 2019. During the inspection, an FDA investigator determined that your firm is a medical device manufacturer of various Class I & II medical equipment,...
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Company: Fresenius Kabi Date of Enforcement Report: 8/12/2019 Class I PRODUCT The Volumat MC Agilia Infusion System is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood products, into a patient’s body in controlled amounts. The pump administers fluids intravenously via an infusion tubing set and is intended...
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Tired of Cancer, a digital health startup based in the Netherlands, announced their release of a mobile app for fighting cancer related fatigue (CRF).  The Untire App is the first of its kind and aims to improve the quality of life for cancer patients and survivors. Thirty to forty percent of cancer patients suffer from...
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Company: Philips Medical Systems Nederlands Date of Enforcement Report: 8/7/2019 Class II PRODUCT Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Recall Number: Z-1997-2019 REASON Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion’s automatic exposure control...
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Company: Elekta Inc Date of Enforcement Report: 8/7/2019 Class II PRODUCT Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System Recall Number: Z-2091-2019 REASON When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle,...
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Company: Mississippi Valley Reg Bld Ctr Date of Enforcement Report: 8/7/2019 Class II PRODUCT Red Blood Cells, Leukocytes Reduced Recall Number: B-0768-2019 Platelets Recall Number: B-0769-2019 REASON Blood products, collected during a software error with blood mixers, were distributed. RECALLING FIRM/MANUFACTURER Mississippi Valley Reg Bld Ctr on 8/7/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME...
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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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