29

Sep

2011

Cl ll Toshiba AQUILION

0

Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report 9/28/11
Class ll:

PRODUCT
1) TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3195-2011;

2) TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3196-2011;

3) TSX-201A: AQUlLlON LB; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3197-2011;

4) TSX-101A: AQUILION 16; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3198-2011

REASON
Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorrectly.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated June 22, 2011.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
155 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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