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FDA issues Class I recall for Philips ultrasound

Eight serious injuries and 4 deaths were reported in association with device issues involving software and connectivity that could disrupt point-of-care imaging.

  • By

  • Teraya Smith

  • October 20, 2026

  • 2 min

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  • 1

    The FDA classified a correction involving Philips Lumify diagnostic ultrasound systems as a Class I recall on October 19.

  • 2

    As of September 29, 2026, the FDA had received reports of 8 serious injuries and 4 deaths associated with Lumify functionality issues.

  • 3

    A software issue may unexpectedly require transducer re-registration, which needs Wi-Fi or cellular connectivity and can prevent scanning until completed.

  • 4

    Unstable or disconnected USB connections may interrupt imaging, while connectivity-related failures pose particular risks in prehospital settings.

  • 5

    Philips advised using Lumify only where network access is readily available unless a backup ultrasound device is immediately available, and is developing a software update.

Original Source(s)

FDA issues Class I recall for Philips ultrasound

  • by Teraya Smith

  • October 20, 2026

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