Recall Z-0816-2015— Philips Ultrasound, Inc.

Name: FDA recall Z-0816-2015
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: K132304. Product: EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.. 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

K132304 — EPIQ DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc.·cleared 2013-08-21

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

EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.

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.