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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion Lightning TSX035A CT Scanner

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  Class 2 Device Recall Aquilion Lightning TSX035A CT Scanner see related information
Date Initiated by Firm April 25, 2016
Date Posted October 06, 2016
Recall Status1 Terminated 3 on July 13, 2017
Recall Number Z-0046-2017
Recall Event ID 74871
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Code Information LL 500
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 has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
FDA Determined
Cause 2		 Software design
Action Toshiba America Medical System, Inc. planned action to bring the defect into Compliance: 1. A notification will be sent to customers with affected systems in compliance with 21 CFR 1003.21 upon approval by the Secretary. The notification letter includes a statement by the correction will be made at no cost to the customer. 2. To correct this issue, modified software will be installed on the systems 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. 3. To avoid this problem in scan planning, the consignee will be advised to do the following until the modified software is installed: a. Confirm that the scan range does not extend beyond the maximum FOV. b. If the ROI for the scan range (indicated by the yellow solid lines) is set as the same size as the maximum FOV (indicated by green dashed lines), the ROI position must be changed. Instructions for changing ROI will be provided as attachments to the notification letter. 4. The modification to the software will be completed within 90 days from the date that the letters are submitted to Toshibas customers. 5. Progress letters will be provided to the Secretary, including the number of electronic products repaired. For further questions, please call (714) 730-5000.
Quantity in Commerce 165
Distribution US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
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.
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