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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 14 Results
510(K) Number: K171850
 
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Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Compute... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ra... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-r... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tom... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Comput... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-r... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomog... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography... 2 10/31/2018 Philips Medical Systems (Cleveland) Inc
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brillia... 2 09/19/2025 Philips North America Llc
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