Recall Z-2109-2014— Philips Ultrasound, Inc.

Name: FDA recall Z-2109-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-09

Class II · Terminated

Class II FDA medical device recall by Philips Ultrasound, Inc., initiated 2014-07-09, terminated 2015-11-06. It names one FDA 510(k) clearance: K152165. Product: QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.. Reason: The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions..

Recalling firm: Philips Ultrasound, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Terminated: 2015-11-06
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K152165 — S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.·cleared 2015-08-26

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

QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

Reason for recall

The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.

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