GE Healthcare, LLC: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

Agency Publication Date: June 19, 2019

Affected Products

Product: Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

CT 610

Product: Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

CT 710

Product: Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

CT 560, 560FX

Product: Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

Discovery IQ

Product: Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

Discovery Ml

Product: Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

Discovery Ml DR

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82982

Status: Active

Manufacturer: GE Healthcare, LLC

Manufactured In: United States

Units Affected: 6 products (1113 in total)

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Sources: FDA iRES · Raw API Response

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