Feb

2011

Cl ll Toshiba TSX-301A AQUILION ONE CT Scanner

Company: Toshiba American Medical Systems Inc
Date of Enforcement Report 2/23/2011
Class ll:

PRODUCT
Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) – Whole Body X-Ray CT Scanner. Recall # Z-1257-2011

REASON
Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, by letter on September 7, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
44 units

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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Cl ll Toshiba TSX-301A AQUILION ONE CT Scanner

Amy Sellers

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