Reported Dec 24, 2014 · Terminated
EPIQ 5 Ultrasound System, EPIQ 5 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 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected
- Model
EPIQ 5GEPIQ 5CEPIQ 5W
- Catalog Number795204 / 795205
- and Part Number989605408541 Diagnostic Ultrasound Imaging
- Lot codes and dates
- SERIAL
- NUMBERS FOR FCO 79500317-EPIQ5 system
88 of 88 codes
US114B0005US114B0006US114C0193US114C0209US114C0239US114C0240US114C0241US114C0271US114C0272US114C0273US114C0284US114C0286US114C0287US114C0308US114C0331US114C0334US114C0366US114C0751US214C0043US214C0106US214C0140US214C0143US214C0144US214C0416US214C0417US314C0199US314C0298US314C0447US314C0728US314C0745US314C0800US314C0801US414C0012US414C0066US414C0114US414C0157US414C0158US414C0159US414C0395US514C0081USD13B0662USD13C0033USD13C0234USD13C0290USD13C0291USD13C0481USD13C0525USD13C0526USD13C0527USD13C0572USD13C0573USD13C0584USD13C0709USN13B0039USN13C0018USN13C0182USN13C0183USN13C0184USN13C0186USN13C0206
- Amount recalled
- 88 units (42 in the US and 46 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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