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January 2021 Standards Navigator
This January 2021 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 1/20/2021 Class II PRODUCT All EPIQ and Affiniti Ultrasound systems. Model numbers – EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD – EPIQ 5 GMDN – 40761 100-240V 50/60 Hz, 600...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 1/20/2021 Class II PRODUCT All EPIQ and Affiniti Ultrasound systems. Model numbers – EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD – EPIQ 5 GMDN – 40761 100-240V 50/60 Hz, 600...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT Atellica CH 930 Analyzer – In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 – Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology...
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Company: Philips North America, LLC Date of Enforcement Report: 1/20/2021 Class II PRODUCT Emission Computed Tomography System Image Process System – Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Recall Number: Z-0852-2021 REASON A software defect that has the potential to result in image...
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Company: Medtronic Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000. Recall Number: Z-0843-2021 REASON Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 1/20/2021 Class II PRODUCT Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 – Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy. Recall Number: Z-0860-2021 REASON A710 Intellis Clinician Application has...
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Company: ICU Medical, Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT icumedical Cogent” Hemodynamic Monitoring System – Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. Recall Number: Z-0859-2021 REASON Due to a potential software issue,...
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Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 1/13/2021 Class II PRODUCT enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN – Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate...
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Company: B Braun Medical, Inc. Date of Enforcement Report: 12/30/2020 Class II PRODUCT APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 – Product Usage: intended for intravascular administration to a patient. Recall Number: Z-0717-2021 REASON There is the potential for the compounding system to not immediately interrupt compounding and alert user to...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 12/30/2020 Class II PRODUCT Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) – Product Usage: intended to be used for the controlled administration of fluids. Recall Number: Z-0712-2021 REASON There is a potential software error during programming. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation on 11/23/2020....
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Company: Haag-Streit USA Inc Date of Enforcement Report: 12/30/2020 Class II PRODUCT Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615...
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62304 Public Training Course DATES:  February 23-25, 2021 Clock time each day TBD COST: 3 Full Days for $2,100.00 This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software, including FDA expectations for software and alignment with 62304, and much more. The course compares and contrasts 62304 with...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 12/23/2020 Class II PRODUCT Percept PC Implantable Neurostimulator (INS) – Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy. Recall Number: Z-0612-2021 REASON A software anomaly...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 12/23/2020 Class II PRODUCT RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7,...
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Company: Remote Diagnostic Technologies Ltd. Date of Enforcement Report: 12/23/2020 Class II PRODUCT Tempus LS – Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 – Product Usage: The device is intended to be used in the following environmental: – Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft). Recall Number:...
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Company: Kowa Optimed Inc Date of Enforcement Report: 12/23/2020 Class II PRODUCT Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras – Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras. Recall Number: Z-0636-2021 REASON It has been determined...
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This December 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...
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Company: Canon Medical System, USA, INC. Date of Enforcement Report: 12/16/2020 Class II PRODUCT Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L – Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. Recall Number: Z-0549-2021 REASON A software problem has been identified which could result in the...
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Company: Shimadzu Medical Systems Date of Enforcement Report: 12/16/2020 Class II PRODUCT Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support – Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures. Recall Number: Z-0554-2021 REASON The firm has identified a problem with...
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Company: Covidien Llc Date of Enforcement Report: 12/9/2020 Class II PRODUCT Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 – Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused. Recall Number: Z-0515-2021 REASON The firm has released software update V01.05.02.16 (also known...
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Company: Biomeme, Inc. Date of Enforcement Report: 12/9/2020 Class II PRODUCT The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative...
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Is it possible to view draft revisions of FDA guidance documents when they are a “work in progress,” or are they only become available once published as draft?  This is a frequent question that I have heard. However, the FDA does not typically provide copies or drafts of “works in progress” for those items that...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 12/2/2020 Class II PRODUCT RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 – Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation...
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Company: Mako Surgical Corporation Date of Enforcement Report: 11/25/2020 Class II PRODUCT Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 – Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register...
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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

Need info?  Email us at training@softwarecpr.com

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