FDAClass IIMay 13, 2020

Philips Brilliance iCT SP Computed Tomography X-Ray recall

Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

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

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

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?

Serial # 200044 Additional unit as off 5/22/20: 200026

Product
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Recalling firm
Philips North America, LLC
Quantity
2
Distribution
Worldwide distribution including one unit distributed to Iowa.
Recall date
May 13, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls