Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Lumify Diagnostic Ultrasound Recalled by Philips Ultrasound, Inc. Due to Color Flow direction is displayed incorrectly in Lumify...
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
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Quantity: 21 units in the US only
Why Was This Recalled?
Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color Bar conveys that Red is to be displayed for color flow toward the Transducer, the system displays Blue for color flow toward the Transducer. This could result in misdiagnosis in some studies.
Where Was This Sold?
This product was distributed to 8 states: CA, CT, NV, ND, OR, RI, TN, WA
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