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.
This recall has been terminated (originally issued April 12, 2016).
- Recall Initiated
- April 12, 2016
- Terminated
- May 19, 2016
- Recall Number
- Z-1560-2016
- Quantity
- 1 unit
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US in the state Nevada
Lot / Code Info
Serial No. 2DA15Y2036
Root Cause
Device Design
Action Taken
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.