Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: 4/11/2025 Class I PRODUCT t:slim X2 Insulin Pump with Interoperable Technology Recall Number: Z-1519-2025 REASON: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate...Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 4/10/2025 Class II PRODUCT Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223 Recall Number: Z-1551-2025 REASON: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. RECALLING FIRM/MANUFACTURER: Siemens Healthcare Diagnostics, Inc. VOLUME: N/A DISTRIBUTION: Domestic:...Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 04/09/2025 Class II PRODUCT BD Pyxis” MedBank” Mini and BD Pyxis” MedBank” Tower, BD Pyxis” MedFlex, BD Pyxis” MedBank” MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings. Recall Number: Z-1545-2025 REASON: Due...Read More
Company: Tornier S.A.S. Date of Enforcement Report: 4/8/2025 Class II PRODUCT stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. Recall Number: Z-1534-2025 REASON: Stryker identified an elevated complaint rate related to difficulties using...Read More
Company: Tornier S.A.S. Date of Enforcement Report: 4/8/2025 Class II PRODUCT stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. Recall Number: Z-1536-2025 REASON: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system...Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 4/8/2025 Class II PRODUCT Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators. Recall Number: Z-1543-2025 REASON: There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming...Read More
Company: Beckman Coulter Inc. Date of Enforcement Report: 4/3/2025 Class II PRODUCT DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC)...Read More
IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software Course Dates: TBD (June 24-26, 2025 public course replaced by a private offering) COST: 3 Full Days for $2,400.00 (Fully transferable at any time.) This course focuses on ensuring the participants are aware of the relevant standards and US regulations that drive the...Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 3/21/2025 Class II PRODUCT Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 Recall Number: Z-1409-2025 REASON: There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. RECALLING FIRM/MANUFACTURER: Baxter Healthcare Corporation VOLUME: 403 units...Read More
SoftwareCPR® Partner and General Manager, Brian Pate, will teach the #aami QSS (Quality System Software) course on April 23rd and 24th, 2025. This course will be hosted by https://www.aami.org/ and runs from 9:00 am EDT to 6:00 pm EDT each day. What is QSS? QSS is all of that software, that is not part of the...Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 3/13/2025 Class I PRODUCT BD Alaris Systems Manager, REF 9601 Infusion Safety Management Software Recall Number: Z-1304-2025 REASON: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). RECALLING FIRM/MANUFACTURER: CareFusion 303, Inc. DISTRIBUTION: US: AZ, CA, DC, FL,...Read More
FDA released a draft guidance document, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” on January 7, 2025. The document provides recommendations on the contents of submissions (be it a 510(k), De Novo, PMA, HDE, or BLA) to FDA for devices that include AI-enabled device software functions and provides recommendations for the...Read More
Refreshing to see such a clearly articulated discussion of #software #design. A good reminder that #softwarequality is “designed-in,” not “tested-in.” Kudos @flightaware https://t.co/CmxySpg6VH — @softwarecpr (@softwarecpr) March 7, 2025 Can #medicaldevice companies rediscover the inherent #quality benefit one gains from well thought out, peer-reviewed software design? This is just one of the topics we will...Read More
Company: MIM Software Inc Date of Enforcement Report: 3/04/2025 Class II PRODUCT MIM software; System, Image Processing, Radiological Recall Number: Z-1252-2025 REASON: In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result. RECALLING FIRM/MANUFACTURER:...Read More
Company: Philips Medical Systems Nederland B.V. Date of Enforcement Report: 2/28/2025 Class II PRODUCT Philips IntelliSpace Cardiovascular software, Model 830089. Recall Number: Z-1252-2025 REASON: Study data is not able to be archived, copied, or exported with the cardiovascular software version. RECALLING FIRM/MANUFACTURER: Philips Medical Systems Nederland B.V. VOLUME OF PRODUCT IN COMMERCE: 139 DISTRIBUTION: US...Read More
Company: LEICA BIOSYSTEMS NUSSLOCH GMBH Date of Enforcement Report: 2/27/2025 Class II PRODUCT Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01 Recall Number: Z-1247-2025 REASON: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue. RECALLING FIRM/MANUFACTURER: LEICA...Read More
Company: INTELERAD MEDICAL SYSTEMS INCORPORATED Date of Enforcement Report: 2/25/2025 Class II PRODUCT IntelePACS (Image Fusion Module) – InteleViewer Recall Number: Z-1208-2025 REASON: A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired...Read More
Company: BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. Date of Enforcement Report: 2/25/2025 Class II PRODUCT DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. Recall Number: Z-1233-2025 REASON: Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates...Read More
Another insight from our software risk management series on software risk analysis considering general microprocessor failures and concerns that should be considered by the software development team. Enjoy! Fourth post on software risk analysis. When we consider general #microprocessor failures and concerns, one generally starts with the processor operating core working outward. For example,...Read More
Are software engineers a commodity that managers can simply plug-n-play expecting a similar outcome? From X … Are software engineers a commodity that organizations can simply plug-n-play expecting a similar outcome? Unlike many other disciplines, software engineering allows a great deal of freedom within the design space. Two different software engineers can produce significantly… —...Read More
Read on for some helpful questions to ask (essentially a “How-To” Guide for GUDID) when following GUDID, based on the recent FDA guidance document, “Global Unique Device Identification Database (GUDID).” “How-To” Guide for GUDID What does the UDI rule require labelers to do? Include a unique device identifier (UDI) on device labels and packages...Read More
Software Risk Management Series: The expectations of US regulations and for IEC 62304 compliance for software can be overwhelming. Software hazards analysis and risk management is certainly one of the more difficult tasks for developing medical devices containing software. In this post we discuss FTA and FMEA/FMECA methods. How do these methods align with specific...Read More
Software Risk Management Series: The expectations of US regulations and for IEC 62304 compliance for software can be overwhelming. Software hazards analysis and risk management is certainly one of the more difficult tasks for developing medical devices containing software. Common questions: What activities should the development team perform? How do we capture the software analysis?...Read More
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)
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
Agile risk management
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)
