12
May
2004

Toshiba American Med Sys Inc Class III

0

Company: Toshiba American Med Sys Inc
Date of Enforcement Report: 5/12/04
Class: III

PRODUCT
Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04.

REASON
Software anomaly. The region of the body was scanned, was different than programmed.

CODE
All serial numbers.

RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc, Tustin, CA, by letters and visits beginning on May 6, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
50.

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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