Toshiba Aquilion CT System TSX-301C
FDA Recall Z-0016-2016 · Posted 2015-10-09
Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-05-08
Date Terminated2016-10-26
Product Quantity459
Reason for Recall
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Firm Action
Toshiba America Medical Planned Action to bring defect into Compliance:
a. A notification will be sent to all consignees with affected systems in compliance with 21 CFR1 003.21 upon approval by the Secretary.
b. To correct this issue revised software will be installed on each system to prevent this occurrence from happening. Each consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available.
c. Each consignee will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems.
CDRH approves the CAP subject to the following conditions:
1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR
1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification.
2. Toshiba America Medical Systems, Inc. will implement this CAP by
February 1, 2016.
If you have any questions please contact your local Toshiba Representative at (800) 521-1968.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Distribution including Puerto Rico
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.