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Philips EPIQ 5 Diagnostic Ultrasound System

by Philips Health Care

510(k) K172607

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

30 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK172607 Date4 Oct 2017ClearedStatusActive

Recalls

31 recalls · 30 ongoing · FDA

  • 21 recalls, same reason

    • Ongoing Z-1622-2026 FDA Class III initiated 5 Sep 2025 on shared 510(k) K172607
    • Ongoing Z-1628-2026 FDA Class III initiated 5 Sep 2025 on shared 510(k) K172607
    • Ongoing Z-2398-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2411-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2367-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2402-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2408-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2410-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2393-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2349-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2405-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2351-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2364-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2385-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2413-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2395-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2380-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2350-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2414-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2355-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2360-2025 FDA Class III initiated 3 Jul 2025

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

  • 9 recalls, same reason

    • Ongoing Z-2061-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607
    • Ongoing Z-2060-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607
    • Ongoing Z-2063-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607
    • Ongoing Z-2065-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607
    • Ongoing Z-2064-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607
    • Ongoing Z-2068-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607
    • Ongoing Z-2052-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607
    • Ongoing Z-2053-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607
    • Ongoing Z-2067-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K172607

    Ultrasound transducer devices were refurbished beyond their useful life.

    • Terminated Z-1843-2020 FDA Class II initiated 30 Aug 2019 on shared 510(k) K172607

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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