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Company: Bebig Isotopentechnik Gmbh Date of Enforcement Report: 12/08/2023 Class II PRODUCT SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System Recall Number: Z-0517-2024 REASON: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. RECALLING FIRM/MANUFACTURER: Bebig Isotopentechnik Gmbh VOLUME OF PRODUCT IN COMMERCE: 2 software licenses in US, 255...
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Fresenius Medical Care AG & Co. KGaA was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: “This inspection revealed that the above devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the...
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Company: AURIS HEALTH INC Date of Enforcement Report: 12/01/2023 Class II PRODUCT Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w Recall Number: Z-0448-2024 REASON: There is the potential that software issues may result in flipped image of the virtual Bronchoscope view. RECALLING FIRM/MANUFACTURER: AURIS HEALTH INC. VOLUME OF PRODUCT IN COMMERCE: 110 units In total DISTRIBUTION:...
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Cybersecurity for legacy medical devices plays a crucial role in healthcare but to remove these devices may pose a greater risk to patient safety, clinical operations, and financial stability than to leave them in service. The challenging task of “securing” these legacy devices is paramount. It must be recognized that overall management of the risk...
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Interesting list from the Central Digital and Data Office of the U.K. Government on using open source development. They provide a handy checklist of things to consider when deciding on open source or proprietary software. https://www.gov.uk/guidance/be-open-and-use-open-source
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Company: Philips North America Date of Enforcement Report: 11/15/2023 Class II PRODUCT Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 Recall Number: Z-0306-2024 REASON: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 11/09/2023 Class I PRODUCT StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as...
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The U.S. Food and Drug Administration (FDA) announced today that AAMI SW96 Receives FDA Consensus Standard status.  Medical device manufacturers are now expected to conform to the requirements of this standard as applicable, or have processes that show address the requirements of the standard. The broad outline of AAMI SW96 is: General requirements for security...
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Company: Impedimed Limited Date of Enforcement Report: 10/24/2023 Class II PRODUCT SOZO Bilateral Arm L-Dex Software Recall Number: Z-0155-2024 REASON: Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could...
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Company: Acclarent, Inc. Date of Enforcement Report: 10/20/2023 Class II PRODUCT TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 Recall Number: Z-0127-2024 REASON: When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended...
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Wavi Co. was issued a warning letter from the FDA for reason of “failure to perform validation of device software as required by 21 CFR 820.30(g).” More specifically, “Your firm distributed at least 90 WAVi Complete Systems consisting of WAVi Headsets, WAVi eSoc single use electrodes, electrode contacts, Electronic Processing Units [EPU], ear clips, Heart...
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Company: EITAN MEDICAL LTD Date of Enforcement Report: 10/19/2023 Class I PRODUCT Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) Recall Number: Z-0094-2024 REASON: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. RECALLING FIRM/MANUFACTURER: EITAN MEDICAL LTD VOLUME...
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Company: OLEA MEDICAL Date of Enforcement Report: 10/18/2023 Class II PRODUCT Functional MR V1.0 Recall Number: Z-0122-2024 REASON: When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to...
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FDA issues a warning letter for Abiomed Inc. for the reason of “Our inspection also revealed the Impella Connect System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act,...
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Company: Blue Belt Technologies, Inc Date of Enforcement Report: 10/05/2023 Class II PRODUCT Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 Recall Number: Z-0041-2024 REASON: CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees...
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Company: Philips North America Llc Date of Enforcement Report: 09/29/2023 Class II PRODUCT EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 Recall Number: Z-2654-2023 REASON: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. RECALLING...
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Company: Philips Healthcare Date of Enforcement Report: 09/29/2023 Class II PRODUCT Incisive CT, software version 5.0 Recall Number: Z-2520-2023 REASON: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 09/29/2023 Class II PRODUCT Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. Recall Number: Z-2657-2023 REASON: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 09/28/2023 Class II PRODUCT BD Pyxis MedBank MedPass Software, REF: 139088-01 Recall Number: Z-2646-2023 REASON: After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to...
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Company: Baxter Healthcare Corp. Date of Enforcement Report: 09/28/2023 Class II PRODUCT Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x. Recall Number: Z-2647-2023 REASON: Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System...
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Company: Exocad GmbH Date of Enforcement Report:9/25/2023 Class II PRODUCT exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy. Recall Number: Z-2633-2023 REASON: A software library filtering error has been discovered which occurs when...
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Sonesta Medical AB was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for,...
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Company: Diversatek Healthcare Date of Enforcement Report: 09/07/2023 Class III PRODUCT ZVU Functional GI Software, REF: ZVU-3 Recall Number: Z-2521-2023 REASON: GI software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. RECALLING FIRM/MANUFACTURER: Diversatek Healthcare VOLUME OF PRODUCT IN COMMERCE: 20 DISTRIBUTION: Worldwide – US Nationwide distribution in the states...
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Lex Inc. was issued a warning letter from the FDA for reason “of vulnerabilities in hardware and software, encompassing both networked and non-networked systems (e.g., programmable logic controller (PLC)).” More specifically, “a list of all software configurations (both equipment software and laboratory information management system (LIMS)) and versions, details of all user privileges, and oversight...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 08/25/2023 Class II PRODUCT RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0 Recall Number: Z-2464-2023 REASON:...
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Company: Stryker Corporation Date of Enforcement Report: 08/25/2023 Class II PRODUCT SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090. Recall Number: Z-2463-2023 REASON: Potential for current software to miscount when scanning in multiple...
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The Open Worldwide Application Security Project (OWASP) released a white paper titled OWASP Top 10 for LLM.  The introduction states, The frenzy of interest of Large Language Models (LLMs) following of mass-market pre- trained chatbots in late 2022 has been remarkable. Businesses, eager to harness the potential of LLMs, are rapidly integrating them into their...
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Recalled Product Product Names: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and 5704813 Product Material Numbers: See Recall Database Entry Distribution Dates: April 30, 2012 to June 13, 2022 Devices Recalled in the U.S.: 300 Date Initiated by Firm: June 12, 2023 Device Use The Oxylog 3000 Plus Emergency and Transport Ventilator is...
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A former employee forges FDA clearance letters at a Philadelphia-area medical device manufacturer.  Peter Stoll III pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce, in violation of 21 United States Code, Section 331(a) and 331(a)(2). ...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 07/21/2023 Class II PRODUCT A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. Recall Number: Z-2226-2023 REASON: When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application...
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Company: Hamilton Medical, Inc. Date of Enforcement Report: 07/21/2023 Class I PRODUCT HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Recall Number: Z-2139-2023 REASON: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop...
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Company: Digisonics, Inc Date of Enforcement Report: 07/20/2023 Class II PRODUCT Digisonics OBView Versions 4.8.2 SP6 – 4.8.3, Ultrasound reporting software Recall Number: Z-2214-2023 REASON: Software issue RECALLING FIRM/MANUFACTURER: Digisonics, Inc VOLUME OF PRODUCT IN COMMERCE: 32 units DISTRIBUTION: US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY,...
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Company: Beckman Coulter Biomedical GmbH Date of Enforcement Report: 07/14/2023 Class II PRODUCT Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Recall Number: Z-2144-2023 REASON: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 07/13/2023 Class I PRODUCT SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Recall Number: Z-2103-2023 REASON: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported...
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Tampa, FL, July 13, 2023. Crisis Prevention and Recovery, LLC, dba SoftwareCPR® is pleased to announce that our partner, Dr. Peter Rech, has received the Certified Information Systems Security Professional (CISSP) prestigious certification.  Peter has led the SoftwareCPR staff in cybersecurity related activities for our clients and is one of the premier regulatory experts with...
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In May 2023, FDA centers CDER and CBER released guidance on the integration of risk with quality management.  Per FDA, these “principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.”  The guidance covers the general quality risk management process but discusses the roles and responsibilities...
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ZYTO Technologies was issued a warning letter from the FDA for the reason of “the ZYTO Hand Cradle GSR and associated proprietary software is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act,...
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ZYTO Technologies, Inc. was issued a warning letter from the FDA for reason “your firm is promoting the ZYTO Hand Cradle GSR and associated proprietary software outside its cleared intended use.” More specifically, Our inspection revealed that the ZYTO Hand Cradle GSR and associated proprietary software is adulterated under section 501(f)(1)(B) of the Act, 21...
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Company: RaySearch America Inc Date of Enforcement Report: 07/03/2023 Class II PRODUCT Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Recall Number: Z-2039-2023 REASON: A software bug affecting results when...
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Company: Philips North America Llc Date of Enforcement Report: 06/29/2023 Class II PRODUCT DigitalDiagnost C90, Model No. 712034 and 712035 Recall Number: Z-2042-2023 REASON: There is a software login in issue that may prevent the user from logging in. RECALLING FIRM/MANUFACTURER: Philips North America Llc VOLUME OF PRODUCT IN COMMERCE: 58 DISTRIBUTION: Distribution in US:...
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Company: Appliedvr Date of Enforcement Report: 06/29/2023 Class II PRODUCT RelieVR REF: RVX-2002, Rx Only Recall Number: Z-2044-2023 REASON: There is the potential for the program software to malfunction which will not allow it to move forward to the next session. RECALLING FIRM/MANUFACTURER: Appliedvr VOLUME OF PRODUCT IN COMMERCE: 1 unit DISTRIBUTION: US: NY OUS:...
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In March 2023, FDA released a draft guidance on Part 11 Application to Clinical Investigations.  The specific introduction in the guidance stated: This document provides guidance to sponsors, clinical investigators, institutional review boards(IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations...
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Company: SenTec AG Date of Enforcement Report: 06/20/2023 Class II PRODUCT V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). Recall Number: Z-1980-2023 REASON: The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode “production” and were not reset to “released” mode. RECALLING...
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Company: Illumina, Inc. Date of Enforcement Report: 06/16/2023 Class II PRODUCT NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software Recall Number: Z-1976-2023 REASON: Cybersecurity vulnerability concerning the software used for sequencing instruments. RECALLING FIRM/MANUFACTURER: Illumina, Inc. VOLUME OF PRODUCT IN COMMERCE: 1067 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries...
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Company: Datascope Corp. Date of Enforcement Report: 06/14/2023 Class III PRODUCT Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...
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Company: Datascope Corp. Date of Enforcement Report: 6/14/2023 Class III PRODUCT: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...
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FDA releases Final Guidance on Content of Premarket Submissions for Device Software Functions.  This final guidance provides requirements for the recommended documentation manufacturers should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s Guidance for the Guidance for the Content of Premarket...
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Tampa, FL, May 10, 2023.  Crisis Prevention and Recovery, LLC, dba SoftwareCPR® announced today that Windi has joined SoftwareCPR® as a Partner. In her role, Windi will lead the expert regulatory and quality team, bringing a unique client-side perspective for both US, Canada, UK/EU, and Japan markets. Windi’s career path is one marked by a...
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The FDA completed its review of an Automated Ejection Fraction SaMD De Novo leading to a new Class II code, ‘QVD.’  The FDA notice follows including the special controls. FDA Notice Re: DEN220063 Trade/Device Name: Caption Interpretation Automated Ejection Fraction Software Regulation Number: 21 CFR 892.2055 Regulation Name: Radiological machine learning-based quantitative imaging software with...
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Company: BioReference Health, LLC Date of Enforcement Report: 06/02/2023 Class II PRODUCT The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates...
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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.

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Being Agile & Yet Compliant (Public or Private)

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

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

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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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)

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