Company: Philips Ultrasound, Inc.
Date of Enforcement Report 12/24/2014
Class lI:
PRODUCT
QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
Recall Number Z-0815-2015
REASON
When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA on 11/5/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
417 units (289 in the US and 128 outside US)
DISTRIBUTION
Nationwide and Internationally
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