FDA Enforcement
Class II
Terminated
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Recall: Z-2188-2016
·
Reported July 27, 2016
Enforcement
- Recall Number
- Z-2188-2016
- Event ID
- 74473
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Toshiba American Medical Systems Inc
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- July 27, 2016
- Initiation Date
- February 24, 2016
- Classification Date
- July 18, 2016
- Termination Date
- April 25, 2017
- Address
- PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States
Description
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Reason
During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
Code Info
Model Number - XIDF-AWS801
Distribution
US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
Quantity
23