Philips Ultrasound, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0284-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

Product Classification:

Class II

Date Initiated: October 9, 2023

Date Posted: November 15, 2023

Recall Number: Z-0284-2024

Event ID: 93218

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.

Status: Completed

Product Quantity: 7 systems

Code Information:

Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292

Distribution Pattern:

US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada

Voluntary or Mandated:

Voluntary: Firm initiated