FDA issues early alert on Philips Lumify ultrasound system software and connection problems
The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a software application or a transducer connection that can cause loss of scanning capability or delays in imaging.
Philips Ultrasound sent a letter to affected customers on September 24, 2026, advising that all Lumify units running specific iOS and Android software versions be used only in locations with reliable Wi‑Fi or cellular coverage, and that a backup ultrasound device be readily available. The alert lists the exact product identifiers and software versions that are impacted.
Users are instructed to follow the updated use instructions and to monitor the FDA webpage for further information as it becomes available. The guidance aims to prevent unintended interruptions in clinical scanning while a longer‑term solution is developed.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Diagnostic Ultrasound System Issue from Philips Ultrasound”
read at fda medwatch ↗
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