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U.S. Department of Health and Human Services

Class 2 Device Recall Celesteion PET/CT system

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  Class 2 Device Recall Celesteion PET/CT system see related information
Date Initiated by Firm April 24, 2016
Date Posted May 04, 2016
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-1607-2016
Recall Event ID 74005
510(K)Number K140651  
Product Classification System, tomography, computed, emission - Product Code KPS
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.
Code Information Serial No. 3BA1572002, 3BA1562001, 2881492002
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact Paul Biggins
714-730-5000
Manufacturer Reason
for Recall		 Potential degradation of detector performance.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 3 units
Distribution US Distribution to WI and NV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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