20
Jul
2005

Inc Class II Toshiba American Med Systems

0

Company: Toshiba American Med Systems, Inc
Date of Enforcement Report: 7/20/05
Class: II

PRODUCT
Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart Vantagae, Recall # Z-0986-05

REASON
Patient information A is displayed with images of patient B.

CODE
All codes

RECALLING FIRM
Recalling Firm: Toshiba American Med Systems, Inc, Tustin, CA, by letter on May 25, 2005. Technicians will correct the software by visit beginning on May 25, 2005. Manufacturer: Matsushita Communication Industrial Co., Ltd, Hanishina-Gun, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
103 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.

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