FDAClass IINovember 27, 2013

Brilliance iCT Computed Tomography X-Ray System recall

Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce…

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

If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.

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 #728306, Serial #'s: 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024 and 100025.

Product
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
9 units
Distribution
Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.
Recall date
November 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls