Agency classClass IIOur severity:High FDA (Devices)·Z-0816-2015·Announced 2014-12-24

Philips EPIQ 5 Ultrasound System Recalled for Incorrect Ejection Fraction Calculations

Philips is recalling EPIQ 5 Ultrasound Systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or delayed therapy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the defect could lead to misdiagnosis or incorrect therapy, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Philips Ultrasound, Inc. is recalling EPIQ 5 Ultrasound Systems (models EPIQ 5G, EPIQ 5C, and EPIQ 5W) equipped with software versions 1.0.x or 1.1.x and the QLAB Auto 2D Quantification (a2DQ) and/or Auto Cardiac Motion Quantification (aCMQ) plug-ins. The recall affects 88 units, with 42 located in the United States and 46 outside the US. The affected systems were distributed worldwide, including in numerous US states and international countries.

The recall is due to a software defect where the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than values calculated by manual tracing without the QLAB applications. This discrepancy in EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy for patients.

Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Philips Ultrasound, Inc. for instructions on how to resolve the issue, which may involve software updates or other corrective actions.

The recalled product

Product: EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
Manufacturer: Philips Ultrasound, Inc.
Category: Medical Device — Diagnostic Ultrasound
Hazard: misdiagnosis
incorrect-therapy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

SERIAL NUMBERS FOR FCO 79500317-EPIQ5 system: US114B0005
US114B0006
US114C0193
US114C0209
US114C0239
US114C0240
US114C0241
US114C0271
US114C0272
US114C0273
US114C0284
US114C0286
US114C0287
US114C0308
US114C0331
US114C0334
US114C0366
US114C0751
US214C0043
US214C0106

Distribution

Distributed in 32 states:

Part of a larger recall action

This product is one of 4 recalled by Philips Ultrasound, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Philips Ultrasound, Inc.

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