PlainRecalls
FDA Devices Moderate Class II Terminated

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

Reported: February 3, 2021 Initiated: December 8, 2020 #Z-0727-2021

Product Description

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

Reason for Recall

After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.

Details

Units Affected
91
Distribution
Nationwide
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system. Recalled by PHILIPS HOME HEALTHCARE SOLUTION. Units affected: 91.
Why was this product recalled?
After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0727-2021.