Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:17777
Brand Name:Philips EPIQ 7 Ultrasound System
Model:
Affected:
Software version:V1.0.x/1.1.x with QLAB a2DQ and/or aCMQ plug-ins
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Philips Ultrasound LLC
Issue:When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications to calculate End-Systolic Volume (ESV), the reported ESV may be smaller ESV calculated by manual tracing without the use of QLAB. Correspondingly, the Left Ventricular Ejection Fraction (EF) calculated using these applications may be higher than the EF calculated by manual tracing without the use of QLAB. Philips' investigation has found that this difference may occur in cases where the EF is less than approximately 40%.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:2/12/2014
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