Mar

2006

Inc., Class ll Toshiba America Medical Systems

Company: Toshiba America Medical Systems, Inc.,
Date of Enforcement Report:3/8/2006
Class:Il

PRODUCT
Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film device for diagnostic fluoroscopic imaging, Recall # Z-0533-06

REASON
Systems are defective under 21 CFR 1003.2 in that they may deliver radiation unintended to their use.

CODE
Serial numbers D4622390, D4622394, D4623349, D4612382, D5512402.

RECALLING FIRM/MANUFACTURER
Toshiba America Medical Systems, Inc., Tustin, CA, by software installation beginning on February 22, 2006. Firm initiated recall is on going.

VOLUME OF PRODUCT IN COMMERCE
5 systems

DISTRIBUTION
Nationwide

About the author

Amy Sellers

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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Inc., Class ll Toshiba America Medical Systems

Amy Sellers

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