FDAClass IIOctober 15, 2014

Philips Healthcare Integris Allura 15 -12 Fluoroscopy x recall

Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

Why was Philips Healthcare Integris Allura 15 -12 Fluoroscopy x recalled?

Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

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?

Model Number: Integris Allura 15-12 Serial Number: 16741023

Product
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Recalling firm
Philips Medical Systems, Inc.
Quantity
one system
Distribution
US distribution to FL
Recall date
October 15, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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