5 Key Takeaways

• 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.