PHILIPS HOME HEALTHCARE SOLUTION recalls ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

Recall date

December 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0727-2021

FDA classification

Class II

Brand / firm

PHILIPS HOME HEALTHCARE SOLUTION

Sold / distributed

Nationwide

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system