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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
Recalled May 11, 2016 · FDA recall Z-1607-2016 · Toshiba American Medical Systems
Hazard
Potential degradation of detector performance. · FDA Class II
Units
3 units
Sold at
US Distribution to WI and NV.
Description
Potential degradation of detector performance.
Product
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.
Manufacturer(s)
Toshiba American Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →