Official recall notice

FDA DeviceClass IINotable

Philips EPIQ Elite Diagnostic Ultrasound System Recall (Sep 2026)

Product: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Recall date
2026-09-30
FDA class
Class II

Why it was recalled

Hazard

Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

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Product description

Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

Affected products

All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125

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