FDA-Device2013-04-10Class II
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Philips Medical Systems (Cleveland) Inc
Hazard
Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.
Sold states
Distributed to one customer in Ohio.
Affected count
1
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1029-2013Don't want to check this manually?
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