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Company:oshiba American Medical Systems Inc Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0016-2018 REASON During a bolus tracking...
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Supersedes 1997 guidance. FDA issued a new Final guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” dated Oct. 25, 2017. TThe full guidance is at the link provided. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes specifically. Deciding When...
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Company:Beckman Coulter Inc.. Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012....
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Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0015-2018 REASON During a bolus...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Ingenuity Core128 Xray Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0018-2018 REASON During a bolus tracking...
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FDA published a draft guidance “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff” dated 10/25/17. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for certain medical devices...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Brilliance iCT Xray Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0019-2018 REASON During a bolus tracking...
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The EU has proposed a new regulation on cybersecurity.  While this regulation is not specific to the health sector, health is mentioned as critical infrastructure in the proposal. The proposal would provide a revised mandate, objectives, and tasks for ENISA, the “EU Cybersecurity Agency.”  The new tasks include: Facilitating the establishment and take-up of European...
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SoftwareCPR now has a validation blog at the link provided. The latest entry as of 18-Oct-2017 contains some Retrospective Validation Tips provided by SoftwareCPR founder Alan Kusinitz. Earlier entries relate to Part 11, Agile methods, and Health IT. ValidationCPR Blog
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The link provided is to the full text of the current Bill S.1656 in the US Congress titled “Medical Device Cybersecurity Act of 2017.” Note that bills may not pass into legislation or may be heavily modified prior to becoming law. S.1656
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The firm's quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured - remediation required
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The U.S. Food and Drug Administration released guidance document, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff,” dated September 29, 2017. The guidance lists and explains the process for requesting meetings with the FDA. It explains proper use of these meetings, including examples of appropriate...
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A blog post by Brian Pate of SoftwareCPR see the link provided and scroll down. HealthIT and Software as a Medical Device
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SoftwareCPR now has a validation blog at the link provided. ValidationCPR Blog
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Company: Toshiba American Medical Systems Date of Enforcement Report 9/20/2017 Class lI: PRODUCT Toshiba Medical Radrex – i Digital Radiography X-ray systemRadrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of...
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Company:Baxter Healthcare CorpDate of Enforcement Report 9/20/2017 ClasslI: PRODUCT Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 Recall Number Z-3133-2017 REASON The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette....
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Company:Mako Surgical Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Recall Number Z-3131-2017 REASON Software discrepancy of not showing all...
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Company:Mako Surgical Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Recall Number Z-3130-2017 REASON Software discrepancy of not showing...
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Company:Boston Scientific Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving...
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The PMA CtQ pilot program aims to evaluate device design and manufacturing process quality information early on, giving the applicants the option of foregoing the standard PMA pre-approval inspection
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"AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems" available for purchase
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Participation in the PMA CtQ pilot program is voluntary and the program aims to evaluate device design and manufacturing process quality information early on to assist FDA in its review of the PMA manufacturing section and post-approval inspections. This voluntary pilot program is part of the FDA’s ongoing Case for Quality effort to apply innovative...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 9/13/2017 Class lI: PRODUCT Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical...
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Significant violations of CGMP regulations due to failure to maintain adequate written records of major equipment maintenance and data integrity issues
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The FDA issued the final guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance addresses medical devices that exchange information; whether wired or wireless, or through the internet. It includes unidirectional exchange, bidirectional, or command and control. The guidance focuses on data exchange not physical connection types. It includes a...
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Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a...
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Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into...
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Company:Datascope Corp./MAQUET. Date of Enforcement Report 9/6/2017 Class II: PRODUCT Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. The devices addressed in this communication are the following St. Jude Medical pacemaker and CRT-P devices: Accent, Anthem, Accent MRI, Accent ST, Assurity, Allure...
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On August 29, 2017, the FDA issued “Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers: FDA Safety Communication.” The full document is at the link provided. Firmware Update to Address Cybersecurity Vulnerabilities in Abbott Pacemakers
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Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery Recall Number Z-3050-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that...
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Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery. Recall Number Z-3049-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error...
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The FDA published a list of standards added to their recognition list on August 21, 2017. IEC 82304-1 Edition 1.0 2016-10. Health software part 1: General requirements for product safety are included on this list in the Software/Informatics Section, along with a number of other standards related to device communication (including specifics of glucose meters...
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Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...
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Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...
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Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...
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UL 2900-1 Ed.1 2017 Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements was recognized by FDA on August 21, 2017. See at: FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047.
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This SoftwareCPR.com newsletter in .pdf form lists items added to the website from late-April of 2017 through mid-August of 2017. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or...
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The FDA published a FAQ for companies that may be interested in participating in the Digital Health Software Precertification Program.
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Company:Soft Computer Consultants, Inc.Date of Enforcement Report 8/9/2017 ClasslI: PRODUCT SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, Recall Number Z-2865-2017 REASON Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent...
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The FDA held a meeting and webcast regarding initial development of its new approach for Digital Health Regulation. The FDA’s Digital Health Precertification webpage is at the link provided, and the slides from their presentation can be downloaded.
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"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"
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Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 Class lI: PRODUCT CS 100i Intra-Aortic Balloon Pump. Recall Number Z-2736-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a...
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Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 ClasslI: PRODUCT CS 300 Intra-Aortic Balloon Pump Recall Number Z-2738-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient...
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Company:Beckman Coulter Inc.. Date of Enforcement Report 8/2/2017 Class lII: PRODUCT Beckman Coulter PK7300(R) Automated Microplate System, Catalogue Numbers: N3209000 and N2007600y Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number B-0741-2017 REASON Beckman Coulter’s PK7300, associated with a defect or glitch with the dispensing monitoring board, was distributed.. RECALLING FIRM/MANUFACTURER Bedkman Coulter, Brea, CA...
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Company:Draegar Medical Systems, Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number Z-2734-2017 REASON Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.. RECALLING FIRM/MANUFACTURER Draegar...
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Company:Medtronic Navigation Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Recall Number Z-2746-2017 REASON Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user...
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Company:AGFA Healthcare Corp. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Agfa Healthcare NX 3.0.8950 Imaging Processing Software Recall Number Z-2735-2017 REASON A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server...
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FDA issued a new draft guidance entitled”Draft Guidance for Industry; How To Prepare a Pre-Request for Designation”. This guidance is intended to describe informal interaction with FDA that might lead to a formal Designation request to determine wether a product will be regulator as a device or a drug and some combination thereof. The full...
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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 with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Virtual, Live)

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Email training@softwarecpr.com for more info.

 


 

Being Agile & Yet Compliant (Public)

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

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

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • TBD
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

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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