FDAClass IIJanuary 17, 2018

CombiDiagnost R90 Image-Intensified fluoroscopic x-ray recall

CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all…

Why was CombiDiagnost R90 Image-Intensified fluoroscopic x-ray recalled?

The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.

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 CombiDiagnost R90 UDI 709030

Product
CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all…
Recalling firm
Philips Electronics North America Corporation
Quantity
10
Distribution
Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.
Recall date
January 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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