CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

• 2 recalls, same reason

  • Ongoing Z-2361-2025 FDA Class III ·initiated 3 Jul 2025
  • Ongoing Z-2370-2025 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-1841-2020 FDA Class II ·initiated 30 Aug 2019 ·on shared 510(k) K162329

  The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury

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

510(k) Number

K162329 ↗

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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