Day

July 17, 2025
17
Jul

FDA Recall: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available

July 17, 2025
Company: Medtronic, Inc. Date of Enforcement Report: 7/17/2025 Class: II PRODUCT Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR...
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17
Jul

FDA Recall: Infusion pumps may have an incorrect version of software

July 17, 2025
Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/17/2025 Class: I PRODUCT Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Recall Number: Z-2095-2025 REASON: Certain Spectrum infusion pumps may have an incorrect version of software. RECALLING FIRM/MANUFACTURER: Baxter Healthcare Corporation VOLUME: 14 units DISTRIBUTION: US States: CA, FL, IL, KS, MI, MS, NY, OH,...
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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