Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:17044
Brand Name:Philips Ultrasound QLAB
Model:453561704771 and 45356182801
Affected:
Software version:10.0 amd 10.1
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:Manufacturer advise of a problem with the Philips Ultrasound QLAB that could result in the erroneous caculation of Ejection Fraction (EF) from the results of using a2DQ and aCMQ patient exams.This miscalculation can only occur in QLAB versions 10.0 and 10.1 on a PACS or with Thiurd Party PACS integration.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:28/7/2014
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