The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0817-2015·Announced 2014-12-24

Philips EPIQ 7 Ultrasound Systems Recalled for Incorrect Ejection Fraction Calculations

Philips is recalling EPIQ 7 ultrasound systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or incorrect 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 is classified as FDA Class II, and the source text explicitly states that the defect could lead to misdiagnosis and/or delayed or incorrect therapy, which constitutes a risk of harm where injury has not yet been reported.

Plain-English summary

Philips Ultrasound, Inc. is recalling EPIQ 7 Ultrasound Systems (models EPIQ 7G, EPIC 7C, and EPIQ 7W) equipped with software versions 1.0.x or 1.1.x that include the QLAB Auto 2D Quantification (a2DQ) and/or Auto Cardiac Motion Quantification (aCMQ) plug-ins. The recall affects 701 units, with 237 located in the United States and 464 distributed internationally.

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. This discrepancy could result in an incorrect EF calculation, which may lead to patient misdiagnosis and/or delayed or incorrect therapy.

Healthcare facilities and users should check their EPIQ 7 systems for the affected software versions and plug-ins. Affected units should be taken out of service for the specific QLAB applications mentioned until a software update is available. Philips is contacting customers directly to provide instructions for the corrective action.

The recalled product

Product
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging.
Manufacturer
Philips Ultrasound, Inc.
Category
Medical Device — Diagnostic Imaging
Hazard

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 079500318- EPIQ 7 SYSTEM: US114B0038
  • US114B0040
  • US114B0055
  • US114B0091
  • US114B0111
  • US114B0112
  • US114B0113
  • US114B0114
  • US114B0115
  • US114B0125
  • US114B0128
  • US114B0129
  • US114B0161
  • US114B0185
  • US114B0186
  • US114B0201
  • US114B0204
  • US114B0225
  • US114B0235
  • US114B0236

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 →

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