FDAClass IIDecember 24, 2014

Philips Brilliance iCT Computed Tomography X-Ray System recall: Software Issue

Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System…

Why was Philips Brilliance iCT Computed Tomography X-Ray System recalled?

It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

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?

Software version 4.1.

Product
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System…
Recalling firm
Philips Medical Systems, Inc.
Quantity
16 systems
Distribution
US Distribution
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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