FDA flags loss-of-scanning risk in Philips Lumify ultrasound systems
FDA’s early alert warns users to plan for connectivity-related registration failures and possible cable disruptions that can delay scanning.
What the record says
The October 9 notice concerns listed Lumify Android and iOS systems. FDA says unexpected transducer re-registration can prevent scanning without Wi-Fi or cellular access, particularly outside hospitals. Philips is developing a software update; the notice does not report it available.
FDA notice current October 9, 2026.
Registration can require network access before scanning resumes.
Philips’ U.S. customer-care number is 800-722-9377.
Source details and supporting locations.
Practical next step
Clinical users should only use Lumify where Wi-Fi or cellular service is readily accessible unless a backup ultrasound device is immediately available. Always keep backup devices or modalities available, circulate and post Philips’ customer notice, and match the exact software and device identifiers in FDA’s table.
Limits and what is not established
This is an early alert under FDA review. It does not establish that every Lumify system has failed or that a software fix is ready. Patients should discuss care concerns with their provider rather than change care based on this summary.
Sources checked October 11, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information