Philips Ultrasound Llc IYNClass II

System, Imaging, Pulsed Doppler, Ultrasonic

Philips Ultrasound Llc's record for this product code

MDR events4All time

Recalls2All time

510(k) clearances24All time

Recent MDR events

4 adverse event reports on file

Recalls

2 recall events for this product code

CompletedDec 31, 2025
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
View FDA record ↗
Open, ClassifiedDec 4, 2025
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
View FDA record ↗

510(k) clearances

24 clearances for this product code