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Philips Ultrasound, Inc. recalls QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view an
Recalled July 30, 2014 · FDA recall Z-2109-2014 · Philips Ultrasound
Hazard
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. · FDA Class II
Units
25 units total (2 units in the US and 23 units outside the US)
Sold at
Distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI. Also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.
Description
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
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.
Manufacturer(s)
Philips Ultrasound, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →