Toshiba Medical Systems Angiography Cl II

Company:Toshiba America Medical Systems, Inc.,
Date of Enforcement Report:12/5/2007
Class:ll

PRODUCT
Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008

REASON
System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba America Medical Systems, Inc., Tustine, CA, by letters beginning on October 2, 2007.
Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Otawara-Shi, Tochigi, Japan. Firm initiated recall is ongoing. .

VOLUME OF PRODUCT IN COMMERCE
23 units

DISTRIBUTION
Nationwide

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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