Home / Recalls / Philips Medical Systems (Cleveland) Inc / Z-0302-2019

Z-0302-2019 Class II Terminated

Recalled by Philips Medical Systems (Cleveland) Inc — Cleveland, OH

Recall Details

Product Type
Devices
Report Date
November 7, 2018
Initiation Date
September 4, 2018
Termination Date
May 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
61 units

Product Description

Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines 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.

Reason for Recall

Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.

Distribution Pattern

US Nationwide Distribution

Code Information

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

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