FDA-Device2013-03-06Class II
Ingenuity TF PET/CT. Diagnostic imaging system
Philips Medical Systems (Cleveland) Inc
Hazard
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
Sold states
Distributed only in Ohio.
Affected count
1 Unit
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Ingenuity TF PET/CT. Diagnostic imaging system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0897-2013Don't want to check this manually?
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