Jun

2011

SSH-880CV Aplio Artida Diagnostic ultrasound Cl ll

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

PRODUCT
Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound. Recall # Z-2203-2011.

REASON
Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values..

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

VOLUME OF PRODUCT IN COMMERCE
28 units

DISTRIBUTION
Internationally

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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SSH-880CV Aplio Artida Diagnostic ultrasound Cl ll

Amy Sellers

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