Day

March 1, 2024
Company: CareFusion 303, Inc. Date of Enforcement Report: 3/01/2024 Class II PRODUCT BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352 Recall Number: Z-1223-2024 REASON: Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result...
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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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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

Or just email training@softwarecpr.com for more info.

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