Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2019 - (Recall #: Z-1929-2019)

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.

Class II

The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.

Serial Nos. 900050 900036 900047 900042 900019 900055 900063 900048 900045 900011 900037 900044 900007 900049 900017 900067 900058 900020 900035 900032 900024 900064 900040 900054 900025 900030 900005 900028 900059 900009 900052 900053 900046 900026 900051 900013 900065 900015 900006 900027 900075 900031 900073 900041 900016 900012 900057 900043 900021 900062 900033 900038 900010 900029 900066 900023 900008 900039 900060 900018 900022 900014 900004 900034 900056 900061 900069 900070 900068 900071

Worldwide Distribution - US Nationwide Domestic distribution to CA GA LA MD MI MN MO NE NJ NY OH TN TX VT WI. Foreign distribution to Mexico, Argentina Austria Belgium China Colombia France Germany Israel Italy Japan Latvia Luxembourg Netherlands Portugal Singapore Spain Switzerland

Voluntary: Firm initiated