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Recall Observatory FDA recall evidence

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

April 24, 2016

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
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

    reason.no_named_rule · v1.0.0

    Potential degradation of detector performance.