22
Dec
2004

Toshiba American Med Sys Inc Class II

0

Company: Toshiba American Med Sys Inc
Date of Enforcement Report: 12/22/04
Class: II

PRODUCT
Magnetic Resonance Imaging Systems, under the following names: Visart Excelart P2 Excelart P3 Excelart SPIN. Recall # Z-0273-05.

REASON
Software defect causes patient identification number to be truncated.

CODE
No specific codes were listed.

RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc, Tustin, CA, by letter on August224, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
39

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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