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Wire · regulatory

Philips updates instructions for ultrasound system linked to 4 deaths

12 October 2026 · By · Wire by Fusion42

Published

12 October 2026

Topic

regulatory

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at medtechdive.com →

◆ Verified

Fusion42 · 12 October 2026 · Fusion42 review

Philips updated its instructions for the Lumify diagnostic ultrasound system after a software issue was linked to delays in use, associated with four deaths, particularly in environments without Wi-Fi or cellular signal.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ ◆ The Wire takeaway

You must reassess system dependencies where connectivity issues can cause life-critical delays; this update exposes a new compliance risk in medical device deployment that can stall product adoption and invite regulatory scrutiny.

◆ Coverage

1 source · 12 Oct 2026

◆ Related on Wire

◆ Topics

Medtechphilipsultrasoundsoftware-issuepatient-safetymedical-device