Company: GE Medical Systems, LLC Date of Enforcement Report 8/24/2018 Class II: PRODUCT GE Healthcare MRI Systems, Software Version 11.x Recall Number: Z-0110-2019 REASON The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. RECALLING...Read More
Underwriters Laboratories, Inc. published the First Edition of the Standard for Safety for Remote Software Updates, UL 5500 on September 6, 2018. This standard covers remote software updates, accounting for the manufacturer’s recommended process to ensure safety. It is limited to software elements having an influence on safety and compliance with the particular end product...Read More
This final guidance, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” replaces the 2013 draft guidance. This guidance focuses on clarifying and formalizing existing FDA practice including the requirement to submit FDA’s standards form for each standard used as well as discusses the use of obsolete standards. Originally standards were a...Read More
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John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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