FDAClass IIOctober 1, 2014

Brilliance CT System 6/10/16/16P/40 configuration. No recall

Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional…

Why was Brilliance CT System 6/10/16/16P/40 configuration. No recalled?

The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

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?

728256, 728251, 728246, 728240, and 728235.

Product
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
364
Distribution
Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil.
Recall date
October 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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