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.
Reported: July 30, 2014 Initiated: July 9, 2014 #Z-2110-2014
Product Description
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.
Reason for Recall
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Details
- Recalling Firm
- Philips Ultrasound, Inc.
- Units Affected
- 59 units total (12 units in the US and 47 units outside the US)
- Distribution
- 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.
- Location
- Bothell, WA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips Ultrasound, Inc.. Units affected: 59 units total (12 units in the US and 47 units outside the US).
Why was this product recalled? ▼
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2110-2014.
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