FDAClass IISeptember 20, 2023

Philips Allura Xper recall

Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

Why was Philips Allura Xper recalled?

A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

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?

Models: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 No UDI-DI information for foot switch component.

Product
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity
19,115 systems
Distribution
Worldwide distribution
Recall date
September 20, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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