Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is Recalled by Philips Ultrasound, Inc. Due to The QLAB a2DQ and aCMQ features have a...

Date: July 9, 2014
Company: Philips Ultrasound, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Ultrasound, Inc. directly.

Affected Products

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.

Quantity: 25 units total (2 units in the US and 23 units outside the US)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 10 states: CA, IA, KY, MD, NY, PA, UT, VA, WA, WI

Affected (10 states)Not affected

About Philips Ultrasound, Inc.

Philips Ultrasound, Inc. has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report