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Have there been safety issues or field safety notices with AI-based medical devices?

Anonymous · Published September 18, 2025 · 2 comments
Is anyone aware of any documented safety issues or field safety notices (FSNs) that have been issued for AI-based medical devices? If so, are there specific databases or sources where these incidents can be found?

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Thomas Jensen 9 months ago
MHRA and MAUDE are two commonly used databases for safety notices.
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Charlotte Dubois 9 months ago
IGJ is another database where such notices may be found.
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1 Answer

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
Yes, there have been safety issues reported with AI-based medical devices. You can find documented cases in the MHRA and IGJ databases. For example, we have reported more than one incident, though fortunately with no patient harm. If you want more insights, I’m happy to share more details. I think safety information should be more easily available to everyone!

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All questions
A

Is AI used for image analysis in a medical device always classified as high-risk under the EU AI Act?

Anonymous · 1 comment
9 months ago
I am evaluating the impact of the EU AI Act on a medical device that automates allergy skin prick tests. The process involves pricking a patient's arm with allergens, taking an image, and using AI to
Accepted 2 answers

As of now, there is no official or exhaustive guidance that states every Class IIa or higher medical device using AI is automatically high-risk under

Field Safety Notice

Field Safety Notice

Sven Piechottka

updated about 2 years ago
Questionnaire "Cybersecurity for Medical Devices - Technical Documentation"

Questionnaire "Cybersecurity for Medical Devices - Technical Documentation"

Dr. Oliver Eidel

updated almost 2 years ago

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