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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 12 Results
510(K) Number: K171850
 
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Product Description
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Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator ... 2 11/14/2023 Philips North America Llc
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed ... 2 11/14/2023 Philips North America Llc
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and s... 2 11/14/2023 Philips North America Llc
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
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography... 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
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
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