Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EPIQ 5 Ultrasound System Recalled by Philips Ultrasound, Inc. Due to When using the QLAB Auto 2D Quantification (a2DQ)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Ultrasound, Inc. directly.
Affected Products
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 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
Quantity: 88 units (42 in the US and 46 outside US)
Why Was This 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.
Where Was This Sold?
This product was distributed to 32 states: AK, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, ME, MD, MA, MI, MN, MO, NJ, NY, NC, OH, OR, PA, SC, SD, TN, TX, VA, WA, WI, DC
About Philips Ultrasound, Inc.
Philips Ultrasound, Inc. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report