Diagnostic Equipment

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.