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
