10
Mar
2004

Toshiba American Med Sys Class III

0

Company:Toshiba American Med Sys
Date of Enforcement Report: 3/10/04
Class: III

PRODUCT
Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Recall # Z-0546-04.

REASON
Software anomally causes image slices to be in incorrect order.

CODE
Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with software V4.04*R251 to V4.10*R271.

RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys., Inc., Tustin, CA, by letters on January 28, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
24.

DISTRIBUTION
Nationwide and PR.

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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