FDAClass IIMarch 25, 2020

Integris Allura 9 recall

Integris Allura 9, system codes 722018 722021

Why was Integris Allura 9 recalled?

A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

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?

Serial Codes 8 114 64 906187 41 38 119 75 25 87 67 107 32 97

Product
Integris Allura 9, system codes 722018 722021
Recalling firm
Philips North America, LLC
Quantity
20
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Recall date
March 25, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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