Toshiba American Medical Systems Inc recalls Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acqu…

Recall date

April 24, 2016

Source

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

Recall number

Z-1607-2016

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

US Distribution to WI and NV.

Why it was recalled

Potential degradation of detector performance.

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

What was recalled

Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.