Z-1560-2016Class II

Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03

Name: Z-1560-2016 Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03
Creator: Toshiba American Medical Systems Inc
Published: 2016-04-12
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2016-04-12 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that... on 2016-04-12. FDA classified it as Class II and gives the reason as "Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1560-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-12
Posted: 2016-04-22
Terminated: 2016-05-19
Recalling firm: Canon Medical Systems USA, Inc.
Product: Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Correction letter dated 4/12/16 was sent to a customer to bring to the customer's attention with a potential problem with the Aquilion Lightning CT System iStation cover. The letter informs the customer that the iStation cover may come off due to deficient dimensional geomtry. The letter informs the customer of the problem identified and corrective action to be taken. The customer is instructed to complete and return the attached form and fax it to (877) 349-3054. If the customer has any questions regarding the recall letter, then the customer is instructed to contact Paul Biggins at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 1 unit
Distribution: US in the state Nevada
Product codes and lots: Serial No. 2DA15Y2036

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1560-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1560-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22

Product code JAK

K151833Class IIAquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation / cleared 2015-10-09

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)