Company: Toshiba American Medical Systems Inc
Date of Enforcement Report 2/23/2011
Class ll:
PRODUCT
Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) – Whole Body X-Ray CT Scanner. Recall # Z-1257-2011
REASON
Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, by letter on September 7, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
Nationwide
