FDA Enforcement
Class II
Terminated
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.
Recall: Z-1607-2016
·
Reported May 11, 2016
Enforcement
- Recall Number
- Z-1607-2016
- Event ID
- 74005
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Toshiba American Medical Systems Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 11, 2016
- Initiation Date
- April 24, 2016
- Classification Date
- May 4, 2016
- Termination Date
- February 22, 2017
- Address
- PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States
Description
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.
Reason
Potential degradation of detector performance.
Code Info
Serial No. 3BA1572002, 3BA1562001, 2881492002
Distribution
US Distribution to WI and NV.
Quantity
3 units