FDA-Device2018-02-14Class II
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Philips Medical Systems (Cleveland) Inc
Hazard
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Sold states
One domestic and 1 foreign consignee ( Spain)
Affected count
2
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2018Don't want to check this manually?
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