FDA-Device2021-02-03Class II

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

PHILIPS HOME HEALTHCARE SOLUTION
Hazard

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.

Sold states
Nationwide
Affected count
91
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0727-2021

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