Philips Medical Systems (Cleveland) Inc recalls Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagno…

Recall date

September 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0302-2019

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.