FDAClass IIJune 5, 2024

Philips Allura Xper FD20 system with an ADN7NT patient recall: Software Issue

Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.

Why was Philips Allura Xper FD20 system with an ADN7NT patient recalled?

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

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?

Product number: 722012, UDI/DI: 00884838059054; Serial Number: 2138.

Product
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity
1 unit (US)
Distribution
Domestic: OK International: India, Spain, U.A.E.
Recall date
June 5, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls