Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomog ...

Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
Units Affected:    70
Recall Date:    Jun 3, 2019
Philips Medical Systems (Cleveland) Inc
Mfg Country:
United States
Recall ID:    83187
Product ID:    173945
Enforcement Date:    Jul 10, 2019
Termination Date:    Apr 26, 2021
Last Published:    Apr 26, 2021


Emert Number:    Z-1929-2019
Emert Status:    Terminated