ClearVue850 Diagnostic Ultrasound System

• 7 recalls, same reason

  • Ongoing Z-1625-2026 FDA Class III ·initiated 5 Sep 2025 ·on shared 510(k) K153480
  • Ongoing Z-2347-2025 FDA Class III ·initiated 3 Jul 2025
  • Ongoing Z-2375-2025 FDA Class III ·initiated 3 Jul 2025
  • Ongoing Z-2364-2025 FDA Class III ·initiated 3 Jul 2025
  • Ongoing Z-2403-2025 FDA Class III ·initiated 3 Jul 2025
  • Ongoing Z-2373-2025 FDA Class III ·initiated 3 Jul 2025
  • Ongoing Z-2391-2025 FDA Class III ·initiated 3 Jul 2025

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

• 3 recalls, same reason

  • Ongoing Z-2048-2025 FDA Class II ·initiated 28 May 2025 ·on shared 510(k) K153480
  • Ongoing Z-2062-2025 FDA Class II ·initiated 28 May 2025 ·on shared 510(k) K153480
  • Ongoing Z-2055-2025 FDA Class II ·initiated 28 May 2025 ·on shared 510(k) K153480

  Ultrasound transducer devices were refurbished beyond their useful life.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K153480 ↗

FDA Product Code

IYN

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

• Philips Lumify Diagnostic Ultrasound System Open recall

  Class II

  FDA 510(k) K152899 Active Cleared 30 Oct 2015

• 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

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