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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 10 am EST to 7 pm EST each day COST: 3 Full Days for $2,100.00 Early Bird Discount:  $1795.00 thru January 15, 2021 This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software, including FDA expectations for software and alignment...
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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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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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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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Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001 Recall Number: Z-0461-2021 REASON Potential incorrect validation of results due to...
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Company: LivaNova USA Inc Date of Enforcement Report: 11/25/2020 Class II PRODUCT VNS Therapy AspireSR Generator Recall Number: Z-0462-2021 REASON Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4. RECALLING FIRM/MANUFACTURER LivaNova USA Inc...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Atellica IM 1300 Analyzer – Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 Recall Number: Z-0473-2021 REASON Test Definition scanning may reset custom settings to defaults causing falsely low or...
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Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report: 11/18/2020 Class II PRODUCT Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 Recall Number: Z-0439-2021 REASON The device may detect an incorrect Heater Bag volume which may lead to a ‘Supply Bag Line Blocked’ alarm during treatment. This alarm may cause the...
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Our General Manager and Partner, Brian Pate, along with our expert affiliate, Mike Russell, will be teaching a one-day training course through Irish Medtech/Ibec (https://www.irishmedtechassoc.ie) for Ireland-based medical device and HealthIT companies on Thursday, November 19, 2020.   The course will be delivered virtually/online.  This course condenses the agile topics covered in our 3-day IEC 62304...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/11/2020 Class II PRODUCT ARTIS Icono Interventional Fluoroscopic X-Ray system – Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall Number: Z-0400-2021...
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Company: Boston Scientific Corporation Date of Enforcement Report: 11/11/2020 Class II PRODUCT Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application Recall Number: Z-0319-2021 REASON There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly...
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Medical devices are now considered a subtype of Internet of Things (IoT) devices [(2) https://owasp.org/www-pdf-archive/SecureMedicalDeviceDeployment.pdf]. There is a growing need to properly document the physical off-the-shelf (OTS) subsystem components that a medical device contains. Medical devices are often no longer stand-alone devices which contain only proprietary components. Inattention to additional components may lead to a...
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SoftwareCPR® November 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR® content, software recalls, and software warning letters.  Click here:  https://mailchi.mp/20c005316272/softwarecpr-nov-2020-newsletter-4560492?e=819caeeb16
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Company: GE Healthcare, LLC Date of Enforcement Report: 11/4/2020 Class II PRODUCT Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 – Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0306-2021 REASON There is a potential for a smudge artifact that could be suspect...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 11/4/2020 Class II PRODUCT Merge LIS Recall Number: Z-0289-2021 REASON A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on 1/23/2017. Voluntary:  Firm...
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Company: Pentax of America Inc Date of Enforcement Report: 11/4/2020 Class II PRODUCT 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), Recall Number: Z-0292-2021 REASON There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B)....
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Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 10/28/2020 Class II PRODUCT Synapse PACS Software Version 5.6.1 – Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. Recall Number: Z-0282-2021 REASON FUJIFILM...
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The FDA recently announced the addition of 25 new tools to the Catalog of Regulatory Science Tools to help assess medical devices. CDRH catalogues regulatory science tools on this webpage to help improve the development and assessment of emerging medical technologies. Of the 25 tools added, some items of interest are: Laboratory Accuracy Evaluation of...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 10/21/2020 Class II PRODUCT Artis zee or Artis Q systems (listed below) Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE...
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Company: Brainlab AG Date of Enforcement Report: 10/14/2020 Class II PRODUCT Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery. Recall Number: Z-0056-2021 REASON Brainlab Ultrasound Navigation Software does not support the modification of...
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Company: Devicor Medical Products Inc Date of Enforcement Report: 10/14/2020 Class III PRODUCT Neoprobe GDS Control Unit, Model Number NPCU3 Recall Number: Z-0070-2021 REASON It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 10/7/2020 Class II PRODUCT Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model...
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Company: Blood Bank Computer Systems, Inc Date of Enforcement Report: 10/7/2020 Class II PRODUCT ABO QuickPass Web Portal, Version 1.2.0; ABO QuickPass Web Portal 1.1.0; ABO QuickPass Web Portal 1.0.0 Recall Number: B-0697-2020 REASON Blood Bank software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc. on 9/16/2020. Voluntary:  Firm...
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SoftwareCPR September 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.
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A German woman died with “ransomware attack” as a contributing factor in preventing her from receiving timely care. Media reports indicate that it may be the first death directly linked to a cyberattack on a hospital.  Apparently the closest hospital was under the ransomware attack and could not receive the emergency patient causing the first...
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Company: Inpeco S.A. Date of Enforcement Report: 9/23/2020 Class II PRODUCT FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system – Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to...
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Brazil eliminates a premarket approval pathway, instead allowing for premarket notification. Previously, Brazil has had a “Cadastro” pathway to register Class II medical devices and IVDs. This pathway required more extensive documentation (like a technical dossier) for Class II and higher-risk Class I devices. However, on September 18, 2020, the Brazilian regulatory agency, National Health...
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Company: Life Technologies Corporation Date of Enforcement Report: 9/23/2020 Class II PRODUCT The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem’s COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens...
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Company: Medtronic Inc. Date of Enforcement Report: 9/23/2020 Class II PRODUCT The Guardian Connect App CSS7200 iOS – Product Usage: intended for use by patients with a compatible consumer mobile device. Recall Number: Z-2980-2020 REASON As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous...
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Company: Novarad Corporation Date of Enforcement Report: 9/23/2020 Class II PRODUCT NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. Recall Number: Z-2956-2020 REASON The firm received a report of an atypical...
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62304 Public Training Course DATES:  September 22-24, 2020 (Registration is open through September 21, 2020 as seats remain.) COST: 3 Full Days for $2,100.00 Company Discount:  First two students at full price and then 10% off for any others (up to course size limit) This 62304 Public Training Course provides a clear understanding of the...
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Company: SICAT GMBH & CO. KG Date of Enforcement Report: 9/16/2020 Class II PRODUCT SICAT IMPLANT V2.0 Recall Number: Z-2951-2020 REASON A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 – for the specific export format CMG.DXD. RECALLING FIRM/MANUFACTURER SICAT GMBH & CO. KG on 7/15/2020. Voluntary: ...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 9/16/2020 Class II PRODUCT Merge PACS Recall Number: Z-2944-2020 REASON Measurements done on the Merge PACS generated MPR s may have incorrect measurements. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on 8/6/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 125 total units DISTRIBUTION U.S. Nationwide...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 9/16/2020 Class I PRODUCT BD Alaris System; Alaris PCA Model 8120; P/N P0000031; Rx Only. Infusion pump for Patient Controlled Analgesia. Recall Number: Z-2882-2020 REASON The Alaris PC unit to display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion, or...
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Do you have a medical device cleared under Emergency Use Authorization (EUA) during the COVID-19 crisis? Section 564 of the FD&C Act allows the FDA to issue EUAs to otherwise unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents...
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The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, had previously announced that various medical device reforms would be enacted from 2019 through 2024. The transition period was (and still is) set to end on October 31, 2024. However, this summer, TGA announced a delay in the commencement of the medical device...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 9/2/2020 Class II PRODUCT E.cam or Symbia systems that use foresight detectors – Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to...
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Company: Canon Medical System, USA, Inc. Date of Enforcement Report: 9/2/2020 Class II PRODUCT System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 Recall Number: Z-2885-2020 REASON During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the...
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Company: Biosense Webster (Israel), Ltd. Date of Enforcement Report: 9/2/2020 Class II PRODUCT CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module – Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure....
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 9/2/2020 Class II PRODUCT RayCare, device is stand-alone software – Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Recall Number: Z-2899-2020 REASON When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B...
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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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