Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 6/22/2011
Class ll:
PRODUCT
CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed. Recall # Z-2204-2011
REASON
The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc, Tustin, CA, by letter on April 6, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Internationally
