22
Jun
2011

Cl ll Software for TSX-101A: Aquilion 64; System

0

Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 6/22/2011
Class ll:

PRODUCT
CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed. Recall # Z-2204-2011

REASON
The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc, Tustin, CA, by letter on April 6, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
35 units

DISTRIBUTION
Internationally

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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