FDAFebruary 24, 2016device
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
toshiba american medical systemstoshibatoshiba american
Recall history
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