Device product
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Z-2188-2016
Product summary
- Event
- Event 74473
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23
- Official record key
device-enforcement:Z-2188-2016
Official wording
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 information: Model Number - XIDF-AWS801
Distribution pattern: US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
Derived failure modes
-
Unknown
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.