The Recall Desk
HighFDA (Devices)·Z-0815-2015·Announced 2014-12-24

Philips QLAB Software Recall for Incorrect Ejection Fraction Calculations

Philips Ultrasound is recalling QLAB software versions 10.0, 10.1, and 10.1.1 because automated quantification features may report inaccurate cardiac measurements, potentially leading to misdiagnosis.

What this means for you

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. The hazard involves potential misdiagnosis and delayed therapy due to incorrect cardiac measurements, which fits the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Philips Ultrasound, Inc. is recalling QLAB Quantification Software versions 10.0, 10.1, and 10.1.1 that include the Auto 2D Quantification (a2DQ) and/or Auto Cardiac Motion Quantification (aCMQ) plug-ins. The software is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

The recall is due to a 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 use of QLAB. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.

The recall affects 417 units worldwide, including 289 units in the United States and 128 units outside the US. Affected units are distributed in various US states and numerous international countries. Users should contact Philips Ultrasound for instructions on how to resolve the issue.

The recalled product

Product
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety
Manufacturer
Philips Ultrasound, Inc.
Category
Medical Device — Ultrasound Software
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)

  • 15D5-14041EA3-27F8
  • 1788-H1DD736A-I3B1
  • 20B6-13C298A0-2775
  • 236A-13BD1904-276A
  • 28C1-13DDA15F-27AB
  • 3391-13C7A2EF-277F
  • 3BAD-13B7241B-275E
  • 4549-N20290C7-G3FB
  • 464A-1423BC64-2837
  • 466C-13CCAD3E-2789
  • 5019-S1EC9257-K3CF
  • 5581-V1E1931F-U3B9
  • 5BD9-14234717-2836
  • 6676-148FDF60-290F
  • 685C-H1E69D6E-W3C3
  • 6B10-Q1E11DD2-U3B8
  • 6C00-142DD102-284B
  • 7168-1422D1CA-2835
  • 741C-141D522E-282A
  • 75CF-J1F6A6F5-M3E3

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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