Skip to content

EPIQ Series Diagnostic Ultrasound Systems

by Philips Ultrasound, Inc.

510(k) K202216

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 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 NumberK202216 Date2 Sep 2020ClearedStatusActive

Recalls

8 recalls · 8 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2398-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2404-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2369-2025 FDA Class III initiated 3 Jul 2025
    • Ongoing Z-2414-2025 FDA Class III initiated 3 Jul 2025

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

  • 4 recalls, same reason

    • Ongoing Z-2053-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K202216
    • Ongoing Z-2052-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K202216
    • Ongoing Z-2061-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K202216
    • Ongoing Z-2068-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K202216

    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.

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  • Withdrawn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

Other devices from Philips Ultrasound LLC

See all devices from Philips Ultrasound LLC →