Device product

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

Z-0284-2024

October 09, 2023

Class II

Product summary

Firm: Philips Ultrasound, Inc.
Event: Event 93218
Status: Completed
Classification: Class II
Quantity: 7 systems
Official record key: device-enforcement:Z-0284-2024

Official wording

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.

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

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

software version 10.0 may