Toshiba America Medical Systems Angio WorkS Cl II

Company: Toshiba America Medical Systems Inc.
Date of Enforcement Report 7/27/2016
Class lI:

PRODUCT

Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Recall Number Z-2188-2016

REASON
During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.

RECALLING FIRM/MANUFACTURER
Toshiba America Medical Systems Inc., Tustin, CA on 2/24/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
23

DISTRIBUTION
US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.

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About the author

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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