FDAFebruary 1, 2017device
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
What to do
FDA enforcement status: Terminated
Brands named
toshiba american medical systemstoshibatoshiba american
Recall history
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