Reported Dec 24, 2014 · Terminated
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are…
Philips Ultrasound, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected
- Model
EPIQ 7GEPIC 7CEPIQ 7W
- Catalog Number795200 / 795201
- and Part Number989605386721. Diagnostic Ultrasound Imaging
- Lot codes and dates
- SERIAL NUMBERS
- FOR FCO 079500318- EPIQ 7 SYSTEM
701 of 701 codes
US114B0038US114B0040US114B0055US114B0091US114B0111US114B0112US114B0113US114B0114US114B0115US114B0125US114B0128US114B0129US114B0161US114B0185US114B0186US114B0201US114B0204US114B0225US114B0235US114B0236US114B0266US114B0267US114B0307US114B0335US114B0336US114B0337US114B0355US114B0358US114B0359US114B0360US114B0398US114B0399US114B0400US114B0401US114B0471US114B0473US114B0474US114B0478US114B0493US114B0494US114B0495US114B0508US114B0510US114B0511US114B0527US114B0528US114B0529US114B0530US114B0572US114B0579US114B0580US114B0581US114B0582US114B0596US114B0599US114B0600US114B0601US114B0602US114B0603US114B0604
- Amount recalled
- 701 units (237 in the US and 464 outside US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
This product could cause temporary or reversible health problems — stop using it.
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