Aquilion LB TSX201A/2, 3 CT Scanner 의 리콜

Recall

74871

Class 2

Z-0048-2017

2016-04-25

2016-10-06

Terminated

United States

2017-07-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148646

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.

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.