Philips Lumify Diagnostic Ultrasound System

• 3 recalls, same reason

  • Ongoing Z-2354-2025 FDA Class III ·initiated 3 Jul 2025
  • Ongoing Z-2374-2025 FDA Class III ·initiated 3 Jul 2025
  • Ongoing Z-2373-2025 FDA Class III ·initiated 3 Jul 2025

  To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

• • Terminated Z-0596-2016 FDA Class II ·initiated 9 Dec 2015

  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.

510(k) Number

K152899 ↗

FDA Product Code

IYN

FDA applicant

Philips Healthcare, Inc.

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• ST80I Stress Test System

  Class II

  FDA 510(k) K121638 Active Cleared 18 Jul 2012

• QLAB Advanced Quantification Software

  Class II

  FDA 510(k) K191647 Active Cleared 20 Dec 2019

• Philips EPIQ 5 Diagnostic Ultrasound System Open recall

  Class II

  FDA 510(k) K172607 Active Cleared 4 Oct 2017

• Lumify Diagnostic Ultrasound System Open recall

  Class II

  FDA 510(k) K192226 Active Cleared 6 Sep 2019

• Lumify Ultrasound System Open recall

  Class II

  FDA 510(k) K162549 Active Cleared 3 Oct 2016

• Achieva R4 1.5T and Achieva R4 3.0T Open recall

  Class II

  FDA 510(k) K110151 Active Cleared 22 Mar 2011

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