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.
This recall has been terminated (originally issued May 4, 2016).
- Recall Initiated
- April 24, 2016
- Posted
- May 4, 2016
- Terminated
- February 22, 2017
- Recall Number
- Z-1607-2016
- Quantity
- 3 units
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential degradation of detector performance.
Distribution
US Distribution to WI and NV.
Lot / Code Info
Serial No. 3BA1572002, 3BA1562001, 2881492002
Root Cause
Device Design
Action Taken
Toshiba sent an Urgent Medical Device Correction letter dated April 24, 2016 to all affected customers. The letter informed customers that Toshiba America Medical Systems is bringing attention to a potential problem with the Celestion PET/CT System. The letter informed the customers of a potential degradation of detector performance and informed the customers of the problems and the corrective actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or be sent via email to regulatoryaffairs@toshiba.com. Customers with questions were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.