Toshiba American Medical Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-1560-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 12, 2016

Date Posted: May 4, 2016

Recall Number: Z-1560-2016

Event ID: 73857

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.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial No. 2DA15Y2036

Distribution Pattern:

US in the state Nevada

Voluntary or Mandated:

Voluntary: Firm initiated