FDA-Device2017-06-07Class II
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Toshiba American Medical Systems Inc
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.
Sold states
US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN and NH.
Affected count
US - 70 systems
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2017Don't want to check this manually?
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