FDAClass IIOctober 7, 2020

ProxiDiagnost N90 recall

ProxiDiagnost N90

Why was ProxiDiagnost N90 recalled?

Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

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?

All ProxiDiagnost N90 systems are affected.

Product
ProxiDiagnost N90
Recalling firm
Philips North America, LLC
Quantity
71
Distribution
United States
Recall date
October 7, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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