FDAClass IIFebruary 3, 2021

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray recall

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

Why was ProxiDiagnost N90 Image-intensified fluoroscopic x-ray 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Pending

Product
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Recalling firm
PHILIPS HOME HEALTHCARE SOLUTION
Quantity
91
Distribution
Nationwide
Recall date
February 3, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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