Philips Medical Systems (Cleveland) Inc recalls Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) sy…

Recall date

June 3, 2019

Source

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

Recall number

Z-1929-2019

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

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

Why it was recalled

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.

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, 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.