Philips Ultrasound, Inc.: Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

Hazard

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.

Details from the source

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 Quantity: 7 systems Lot/code info: Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292

UPC codes

00884838106611

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.