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Philips EPIQ Elite ultrasound: Doppler gate display offset prompts field safety notice in Netherlands

🇳🇱 IGJ · Sun 01 Nov 2026

IGJ has published a Philips field safety notice on a roughly 2mm display offset affecting pulsed wave sample volume gates with the C5-1 transducer and Abd Vasc preset.

The Dutch healthcare inspectorate IGJ has published a manufacturer field safety notice (FSN) for the Philips EPIQ Elite diagnostic ultrasound system. The notice is dated 22 October 2026, and the IGJ listing carries the date 2 November 2026 on the English-language PDF.

The issue concerns the C5-1 transducer used with the Abd Vasc tissue-specific preset (TSP) in Pulsed Wave Doppler mode. The on-screen pulsed wave sample volume gate is displayed slightly shallower than the location where the measurement is actually taken. Under default conditions the offset is approximately 2mm.

According to the notice, the effect depends on vessel size and flow. In larger vessels it may reduce the signal, which users can offset by raising the PW Gain. In smaller vessels or stenotic flow, the offset may lead to the severity of a stenosis being underestimated.

Philips Ultrasound LLC is the manufacturer, and Philips Medical Systems Nederland BV is the authorised representative. The notice warns that the problem could delay diagnosis or treatment, and that inaccurate data could lead to misdiagnosis and wrong treatment decisions if not identified or checked against other diagnostic tools. The IGJ page summary does not set out the corrective actions; these are in the four-page PDF.

As general context, a field safety notice is the means by which a manufacturer informs users and the regulator of action taken after a device is on the market, where a risk to users has been identified.

What it means for your team

  • Identify any EPIQ Elite systems in use with the C5-1 transducer and Abd Vasc TSP in PW Doppler mode.
  • Read the full four-page FSN for the manufacturer's corrective instructions, as the IGJ summary does not detail them.
  • Clinical teams should corroborate Doppler findings in small vessels or suspected stenosis with other diagnostic tools, as the notice cautions.
  • Vigilance and quality teams should record receipt of the FSN and track completion of the required actions.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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