FDA recall Z-0284-2024

Philips Ultrasound, Inc. · Class II · device

Product

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.

Distribution

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

Key facts

Status: Completed
Initiation date: 2023-10-09
Report date: 2023-11-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0284-2024