Recall Z-0284-2024— Philips Ultrasound, Inc.

Name: FDA recall Z-0284-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-09

Class II · Completed

Class II FDA medical device recall by Philips Ultrasound, Inc., initiated 2023-10-09. It names one FDA 510(k) clearance: K231190. Product: Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210. Reason: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image..

Recalling firm: Philips Ultrasound, Inc.
Classification: Class II
Status: Completed
Initiated: 2023-10-09
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K231190 — EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC·cleared 2023-05-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

Reason for recall

Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.

Data sourced from openFDA. This site is unofficial and independent of the FDA.