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.

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.

On June 3, 2019, the firm notified their customers of the recall via an "Urgent Field Safety Notice Medical Device Correction" letter. Customers were advised to take the following actions: * The operator is instructed to observe the patient during motorized motion. In case of collision, the operator should use the E-Stop to abort all motions. " The operator is instructed to ensure accessories do not collide with gantry covers. Additionally, ensure that sheets, blankets and/or IV lines are not loose or hanging outside the Patient Pallet. " Ensure the patients arms/hands are positioned appropriately at their side or overhead. If necessary, use the arm restraint strap as described in the IFU. " Instruct the patient to not move their hands during the scan and during any table motions until the operator removes the patient from the scanner at the completion of the study. Philips will deploy Field Change Order (FCO) 88200520 free of charge to address overall cover fit on the affected systems. A Philips Field Service Engineer will contact you to schedule the updates at your site. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).