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Class 2 Device Recall Aquilion Celesteion PCA9000rV2 CT Scanner |
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Date Initiated by Firm |
April 25, 2016 |
Date Posted |
October 06, 2016 |
Recall Status1 |
Terminated 3 on July 13, 2017 |
Recall Number |
Z-0049-2017 |
Recall Event ID |
74871 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product |
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner |
Code Information |
XL 700 |
Recalling Firm/ Manufacturer |
Toshiba American Medical Systems Inc PO Box 2068 2441 Michelle Dr Tustin CA 92780-7047
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For Additional Information Contact |
714-730-5000
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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.
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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
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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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