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ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

FDA Recall #Z-0727-2021 — Class II — December 8, 2020

Recall #Z-0727-2021 Date: December 8, 2020 Classification: Class II Status: Terminated

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.

Recalling Firm

PHILIPS HOME HEALTHCARE SOLUTION — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

91

Distribution

Nationwide

Code Information

Pending

Status

Terminated

Voluntary / Mandated

FDA Mandated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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