Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report 9/28/11
Class ll:
PRODUCT
1) TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3195-2011;
2) TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3196-2011;
3) TSX-201A: AQUlLlON LB; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3197-2011;
4) TSX-101A: AQUILION 16; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3198-2011
REASON
Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorrectly.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated June 22, 2011.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
155 units
DISTRIBUTION
Nationwide
