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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba Celesteion PCA9000A/2 PET/CT System

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 Class 2 Device Recall Toshiba Celesteion PCA9000A/2 PET/CT Systemsee related information
Date Initiated by FirmMay 08, 2015
Date PostedOctober 07, 2015
Recall Status1 Terminated 3 on December 03, 2015
Recall NumberZ-0005-2016
Recall Event ID 71763
510(K)NumberK140651 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductCelesteion PCA-9000A/2 PET/CT System
Code Information Model: TSX-301 CI6A with system software V7.0 SPOO04J
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
FDA Determined
Cause 2		Device Design
ActionPlanned Action by Toshiba Medical America Systems to address the defect: a. A notification will be sent to the customer with affected system in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on the system to prevent this occurrence from happening. The consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. The customer will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.
Quantity in Commerce1
DistributionUS Distribution to the state of Nevada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPS
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