17
Feb
2016

Cl II Toshiba INFX-8000V Bi-Plane X-Ray

0

Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 2/17/2016
Class lI:

PRODUCT

INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Recall Number Z-0752-2016

REASON
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an “abnormal value” and it stopped displaying dose data and the dose data was lost. The following message was displayed, “Dose meter abnormal, Dose info disabled”.

RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc., Tustin, CA on 8/4/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4

DISTRIBUTION
US Nationwide Distribution to OH and NY

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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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