Device 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.
Z-1607-2016
Product summary
- Event
- Event 74005
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1607-2016
Official wording
Reason: Potential degradation of detector performance.
Code information: Serial No. 3BA1572002, 3BA1562001, 2881492002
Distribution pattern: US Distribution to WI and NV.
Derived failure modes
-
Unknown
Potential degradation of detector performance.