Company: Toshiba American Med Sys Inc.,
Date of Enforcement Report 1/16/2008
Class:ll
PRODUCT
Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Recall # Z-0305-2008
REASON
Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters beginning on October 2, 2007.
Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Tochigi, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
Nationwide
