FDA-Device2015-09-09Class II
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Philips Medical Systems (Cleveland) Inc
Hazard
Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.
Sold states
Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.
Affected count
11
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2491-2015Don't want to check this manually?
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