Recall Z-0818-2015— Philips Ultrasound, Inc.

Name: FDA recall Z-0818-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-05

Class II · Terminated

Class II FDA medical device recall by Philips Ultrasound, Inc., initiated 2014-11-05, terminated 2016-08-15. It names one FDA 510(k) clearance: K140808. 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.. 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: Philips Ultrasound, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-05
Terminated: 2016-08-15
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K140808 — Q-STATIONPhilips Ultrasound, Inc.·cleared 2014-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.