FDA-Device2014-07-30Class II
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Philips Ultrasound, Inc.
Hazard
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Sold states
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.
Affected count
59 units total (12 units in the US and 47 units outside the US)
Manufactured in
22100 Bothell Everett Hwy, Bothell, WA, United States
Products
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2110-2014Don't want to check this manually?
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