Guiding clients to effective and efficient compliance and regulatory approvals

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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For anyone involved in software development, the importance of software requirements cannot be minimized. Software requirements provide the definition and explanation of “what the software should do” and “how the software should behave.” The software engineers and developers use the requirements as input to the software design and coding process. The test developers also use...
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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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Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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