This September 2021 Standards Navigator Report content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, our report keeps you...Read More
Company: Philips Ultrasound Inc. Date of Enforcement Report: 9/29/2021 Class II PRODUCT Affiniti Diagnostic Ultrasound Systems: Software Versions: 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121, Affiniti 30 795218, Affiniti 50 795208, Affiniti 50 795118, Affiniti 70 795210, Affiniti 70 795119 Recall Number: Z-2484-2021 REASON Due to a software defect that can intermittently cause the...Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 9/29/2021 Class II PRODUCT Centricity PACS-IW with Universal Viewer – Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Recall Number: Z-2502-2021 REASON Image acquisition failures and synchronization failure with the Centricity Enterprise Archive. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.