Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
This recall has been terminated (originally issued July 18, 2016).
- Recall Initiated
- February 24, 2016
- Posted
- July 18, 2016
- Terminated
- April 25, 2017
- Recall Number
- Z-2188-2016
- Quantity
- 23
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
Lot / Code Info
Model Number - XIDF-AWS801
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Toshiba Medical Systems (TAMS) planned action to bring product into Compliance: 1.TAMS will install the software and perform testing to ensure the software update was effective. 2. The customer notification letter which includes a statement that TAMS will, without charge, remedy the defect or bring the product into compliance. . If you have any questions regarding this, please feel free to contact your local Toshiba representative at (800) 521-1968.