Jun

2017

Toshiba Angio WorkStation Cl II

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.

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Toshiba Angio WorkStation Cl II

Amy Sellers

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