Z-0048-2017Class II

Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner

Name: Z-0048-2017 Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Creator: Toshiba American Medical Systems Inc
Published: 2016-04-25
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2016-04-25 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner on 2016-04-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0048-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-25
Posted: 2016-10-06
Terminated: 2017-07-13
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: XL 700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0048-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0046-2017	Class II	Terminated	FDA Mandated	2016-10-12	2016-10-06
Z-0047-2017	Class II	Terminated	FDA Mandated	2016-10-12	2016-10-06
Z-0048-2017	Class II	Terminated	FDA Mandated	2016-10-12	2016-10-06
Z-0049-2017	Class II	Terminated	FDA Mandated	2016-10-12	2016-10-06

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)