FDAClass IINovember 15, 2023

Veradius Unity Mobile Surgery C-arm recall

Veradius Unity Mobile Surgery C-arm

Why was Veradius Unity Mobile Surgery C-arm recalled?

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

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?

Veradius Neo 497 Veradius Neo 607 Veradius Neo 619

Product
Veradius Unity Mobile Surgery C-arm
Recalling firm
Philips North America
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands
Recall date
November 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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