Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 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
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
Quantity: additional 52 international units; 261 units (73 in the US and 188 outside the US); 417 units (289 in the US and 128 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