Company: Philips Ultrasound, Inc.
Date of Enforcement Report 12/24/2014
Class lI:
PRODUCT
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. Recall Number Z-0818-2015
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
43 units (13 in US and 30 outside US)
DISTRIBUTION
Nationwide and Internationally
___________________________________
