Toshiba American Medical Systems Inc recalls Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

Recall date

February 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2109-2017

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F