FDAClass IIJanuary 17, 2018

Philips Healthcare Brilliance iCT computed tomography recall

Philips Healthcare Brilliance iCT computed tomography x-ray system

Why was Philips Healthcare Brilliance iCT computed tomography recalled?

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

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?

Brilliance iCT - 728306 Devices manufactured 03/05/2009 to present.

Product
Philips Healthcare Brilliance iCT computed tomography x-ray system
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
702
Distribution
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
Recall date
January 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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