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Company: Philips Respironics, Inc. Date of Enforcement Report: 5/23/2024 Class I PRODUCT OmniLab Advanced+ (OLA+) Ventilator Recall Number: Z-1817-2024 REASON: Philips Respironics, Inc. is updating use instructions for OmniLab Advanced+ (OLA+) Ventilator due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss. Philips will correct the affected OLA+ to...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 7/3/2024 Class II PRODUCT BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units Recall Number: Z-2262-2024 REASON: Due to a software issue there is the potential that the PC unit may not connect to the server which could impact wireless data transmission to and...
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Company: Siemens Healthcare Diagnostics Inc Date of Enforcement Report: 6/26/2024 Class II PRODUCT Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 Recall Number: Z-2214-2024 REASON: Siemens Healthineers has...
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Company: Blue Belt Technologies, Inc Date of Enforcement Report: 6/11/2024 Class II PRODUCT CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT – UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence...
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Company: Abbott Medical Group Date of Enforcement Report: 6/7/2024 Class I PRODUCT Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device Recall Number: Z-1921-2024 REASON: System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in...
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Company: Nihon Kohden America Inc Date of Enforcement Report: 6/6/2024 Class II PRODUCT BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility Recall Number: Z-2025-2024 REASON: Due to software issue...
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WARNING LETTER Techlem Medical Corporation was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 671395 Techlem Medical Corporation Mississauga ON December 26, 2023 Inspection Dates: June 19, 2023, through June 22, 2023 Inspection Issue(s): These violations include, but are not limited to, the following: 1. Failure...
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WARNING LETTER Trexo Robotics Holdings, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 673150 Cue Health, Inc. San Diego, CA February 7, 2024 Inspection Dates: on June 3 through June 5, 2023 Inspection Issue(s): “the Trexo devices are adulterated under section 501(f)(1)(B) of...
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Company: Verathon, Inc. Date of Enforcement Report: 6/4/2024 Class II PRODUCT Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor Recall Number: Z-2021-2024 REASON: Due to software issues, there is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. RECALLING...
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SoftwareCPR’s partner Dr. Peter Rech convened the IEC TC62/SC62D/MT23 Infusion Pumps working group meeting held from April 22nd to 26th at the AAMI headquarters in Arlington, VA. The attendants included international experts and guests joining from governmental agencies, infusion pump manufacturers, test houses, and clinical research institutions. Progress was made on a variety topics: Pump...
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Company: Stryker Orthopaedics Date of Enforcement Report: 5/28/2024 Class II PRODUCT Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415 Recall Number: Z-1910-2024...
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Company: Stryker Orthopaedics Date of Enforcement Report: 5/28/2024 Class II PRODUCT Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415 Recall Number: Z-1910-2024...
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Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 5/24/2024 Class II PRODUCT Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. Recall Number: Z-1895-2024 REASON: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does...
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Company: Stryker Leibinger GmbH & Co. KG Date of Enforcement Report: 5/23/2024 Class II PRODUCT 8000-021-002, Scopis ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic...
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Company: Tornier S.A.S. Date of Enforcement Report: 5/22/2024 Class II PRODUCT Stryker Blueprint Software, Catalog #BPUE001 Recall Number: Z-1883-2024 REASON: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval. RECALLING FIRM/MANUFACTURER: Tornier S.A.S....
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Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: May 06, 2024 Class I PRODUCT t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology version 2.7 or later /UDI: 00850006613274 Recall Number: Z-1609-2024 REASON: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 5/9/2024 Class I PRODUCT Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Recall Number: Z-1776-2024 REASON: Due to a software issue, there is the potential for...
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WARNING LETTER CMS# 675673 Cue Health, Inc. San Diego, CA May 9, 2024 Inspection Dates: on 10 dates between October 17, 2023 and November 3, 2023. Inspection Issue(s): “not complying with the following Conditions of Authorization in the Letters of Authorization for EUA200248 and EUA210180. For example: Evidence obtained during the inspection demonstrated that your...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 5/1/2-24 Class II PRODUCT RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System Recall Number: Z-1742-2024 REASON: Potential for reported SSD to be too high. RECALLING FIRM/MANUFACTURER: RAYSEARCH LABORATORIES AB VOLUME OF PRODUCT IN COMMERCE: 9 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries of Algeria,...
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Company: SonarMed Inc Date of Enforcement Report: April 19, 2024 Class I PRODUCT AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. Recall Number: Z-1426-2024 REASON: SonarMed Inc. is recalling the SonarMed Airway monitoring system because of a software issue resulting in failure to detect a partial obstruction within 2.5mm sensors...
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We are pleased to announce our SoftwareCPR® Partner, Dr. Peter Rech, will lead the international working group meeting of IEC TC62/SC62D/MT23 Infusion Pumps as its Convenor. The meeting will be hosted by AAMI at the AAMI headquarters from April 22nd to 25th, 2024, in Arlington, VA. The meeting will be dedicated to the maintenance of...
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The FDA announced today that a Federal District Court has entered a Consent Decree Against Philips Respironics following recall of certain sleep therapy machines. The consent decree includes key provisions aimed to prioritize patient relief and ensure the company’s regulatory compliance. The consent decree comes after Philips recalled certain ventilators, continuous positive airway pressure (CPAP)...
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The DEFENSE IN DEPTH approach is to defend the system against any particular ATTACK using several independent methods. Often these might be referred to as “layers of protection.” Some have described it as the “swiss cheese slices” approach – there may be holes in each layer, but when stacked together they form a protective barrier....
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The U.S. Food and Drug Administration, Center for Devices and Radiological Health announced today that they had qualified a new tool for the evaluation of lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems (UCSF LAD MDDT), through the Medical Device Development Tools (MDDT) program. The University of California San Francisco (UCSF) Lethal...
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Company: Life Technologies Corporation Date of Enforcement Report: 3/29/2024 Class II PRODUCT Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx...
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Guidance Update: FDA revises Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The FDA released a revised draft of the Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program on 15 March, 2024. When finalized, this guidance will supersede both the current version of...
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Company: Landauer Date of Enforcement Report: 3/21/2024 Class II PRODUCT microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059 Recall Number: Z-1349-2024 REASON: Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove...
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Company: Philips Respironics, Inc. Date of Enforcement Report: March 19, 2024 Class I PRODUCT Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal Recall Number: Z-1502-2024 REASON: Philips Respironics, Inc. has notified customers to update to the latest software version (1.05.06.00) of its Trilogy Evo continuous ventilator devices due to a possible power...
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Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 3/11/2024 Class II PRODUCT LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Recall Number: Z-1282-2024 REASON: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable...
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Company: Fresenius Kabi USA, LLC Date of Enforcement Report: March 7, 2024 Class I PRODUCT LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Recall Number: Z-1484-2024 REASON: Fresenius Kabi USA, LLC. is recalling their Ivenix Infusion System (IIS), LVP Software, an infusion pump software. The recall will take the form of a software...
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Today, FDA published a guidance paper for the use of augmented reality (AR) & virtual reality in medical devices. The information from that paper is provide below. Medical Extended Reality (XR), which includes Augmented Reality (AR) and Virtual Reality (VR), has the potential to deliver new types of treatments and diagnostics, transforming how and where...
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Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 3/1/2024 Class II PRODUCT VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Recall Number: Z-1224-2024 REASON: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause...
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Oriented for Central European Time! Registration now for our next “Being Agile and Yet Compliant” Training Course.  Our fall offering is coming up.  Conveniently scheduled to work across many timezones! COURSE DATES: March 7 & 28, 2024 HOURS: TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920 per person Special discounts available...
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SoftwareCPR® partner Mike Russell is attending the AAMI/FDA neXus medical device standards conference this week in Washington D.C., and chairing a panel. This year’s conference has added a third standards success track: application. Accordingly, Mike is chairing a panel session today on “Reducing Submission Rejections and Recalls with Software Standards.” In addition to his experience...
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Company: PTW-FREIBURG Date of Enforcement Report: 2/22/2024 Class II PRODUCT Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology. Recall Number: Z-1181-2024 REASON: Software: If the user excludes voxels from the Gamma calculation that are below a dose...
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One of the cornerstones of a quality management system is the integrity of the quality system records. It should go without saying how critical it is for these records to be truthful, accurate, and genuine. Fraudulent data can lead to an unsafe medical device, or a medical device that does not fully achieve its intended...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 2/16/2024 Class I PRODUCT Baxter Exactamix Pro 1200, REF EXM12DY Recall Number: Z-1001-2024 REASON: An error was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery...
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Company: Smiths Medical ASD, Inc. Date of Enforcement Report: 2/14/2024 Class I PRODUCT Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. Recall Number: Z-2107-2012 REASON: Smiths...
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Company: PHILIPS MEDICAL SYSTEMS Date of Enforcement Report: 2/8/2024 Class II PRODUCT Spectral CT on Rails: Software Version 5.1.0.X, model 728334 Recall Number: Z-1054-2024 REASON: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. RECALLING FIRM/MANUFACTURER: PHILIPS MEDICAL SYSTEMS VOLUME OF PRODUCT IN COMMERCE: US:...
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Shepherdly: A bug prediction & code resilience coverage tool In the context of software development, Resilience Coverage measures the overall protection a pull request has against bugs that can impact large portions of your user base and/or expose observability gaps. When coupled with a Software Quality Risk Score driven by a predictive model, engineers can...
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Company: Thoratec Corp. Date of Enforcement Report: 2/2/2024 Class I PRODUCT 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients....
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 2/1/2014 Class I PRODUCT Smith’s Medical Medfusion Model 3500 Syringe pump Recall Number: Z-0863-2024 REASON: Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4....
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Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 1/30/2024 Class II PRODUCT Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Recall Number: Z-0860-2024 REASON: Loss of connectivity between the FlexArm and the Table due to a software issue. RECALLING FIRM/MANUFACTURER: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VOLUME...
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Learn about the Canadian regulatory framework from SoftwareCPR® partner, Ginny Kwan Gattinger, who will give a presentation at the RAPS Global Regulatory Strategy Conference in Baltimore, MD on March 7, 2024, at 10:30 am EST. The conference is being held at the Hilton Baltimore near the BWI Airport. Ginny will co-present with our affiliate, Karen...
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62304 Public Training Course Course Dates:  June 5-7, 2024 CANCELLED COST: 3 Full Days for $2,900.00 (50% refundable through January 31, 2024. Fully transferable at any time.) Limited number of Early Bird discount coupons (worth $895)  available on a first come-first serve basis.  Use coupon code: (thats three-zero-letter p-letter e-letter r) Early bird discount available...
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Deymond Diagnostics s.r.o. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: The “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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iRythm Technologies, Inc. was issued a warning letter from the FDA. SoftwareCPR comments: This Warning Letter demonstrates the need for: Quality systems to stay compliant (CAPA and complaints!) Regulatory oversight to engineering and marketing activities Really communicating product behavior in the IFU!!” Excerpts from a warning letter of interest to software professionals: “As stated in...
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Company: Philips Healthcare (Suzhou) Co., Ltd. Date of Enforcement Report: 1/5/2024 Class II PRODUCT Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Recall Number: Z-0640-2024 REASON: Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan....
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Company: Boston Scientific Corporation Date of Enforcement Report: 1/5/2024 Class II PRODUCT Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus....
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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.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

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

Registration Link:

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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)

Next public offering:  TBD

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