FDAClass IIMay 24, 2023

CombiDiagnost R90 R1.1 recall

CombiDiagnost R90 R1.1

Why was CombiDiagnost R90 R1.1 recalled?

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114

Product
CombiDiagnost R90 R1.1
Recalling firm
Philips North America
Quantity
25 systems in total
Distribution
US Nationwide
Recall date
May 24, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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