Company: Toshiba American Medical Systems Inc
Date of Enforcement Report 6/7/2017
Class lI:

PRODUCT

Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Recall Number Z-2109-2017

REASON
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.

RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc, Tustin, CA on 2/1/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
70 systems

DISTRIBUTION
Nationwide.

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