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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0303-2019 - Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recons...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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Z-0304-2019 - Brilliance 64 (Model No. 728231), Software version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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Z-0305-2019 - Brilliance iCT (Model No. 728306), Software Version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ra...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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Z-0306-2019 - IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruct...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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Z-0311-2019 - Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstructio...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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Z-0308-2019 - Ingenuity CT (Model No. 728326), software version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray ...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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Z-0309-2019 - Ingenuity Core (Model No. 728321), Software version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ra...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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Z-0310-2019 - Ingenuity Core 128 (Model No. 728323), Software version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of ...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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Z-0307-2019 - Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recon...
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2
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10/31/2018
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Philips Medical Systems (Cleveland) Inc
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