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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion Lightning CT System

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  Class 2 Device Recall Aquilion Lightning CT System see related information
Date Initiated by Firm April 12, 2016
Create Date April 22, 2016
Recall Status1 Terminated 3 on May 19, 2016
Recall Number Z-1560-2016
Recall Event ID 73857
510(K)Number K151833  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03

Product Usage:
Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Code Information Serial No. 2DA15Y2036
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		 Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
FDA Determined
Cause 2		 Device Design
Action An Urgent Medical Device Correction letter dated 4/12/16 was sent to a customer to bring to the customer's attention with a potential problem with the Aquilion Lightning CT System iStation cover. The letter informs the customer that the iStation cover may come off due to deficient dimensional geomtry. The letter informs the customer of the problem identified and corrective action to be taken. The customer is instructed to complete and return the attached form and fax it to (877) 349-3054. If the customer has any questions regarding the recall letter, then the customer is instructed to contact Paul Biggins at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
Quantity in Commerce 1 unit
Distribution US in the state Nevada
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 = JAK and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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