Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 3/30/2011
Class ll:
PRODUCT
SSH-880CV Aplio Artida; System, Diagnostic Ultrasound. Recall # Z-1498-2011
REASON
Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on September 28, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide