Company: Accuray Inc,
Date of Enforcement Report:12/19/2007
Class:ll
PRODUCT
Accuray, Multiplan Treatment Planning Software, Recall # Z-0364-2008
REASON
Software problem – Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.
RECALLING FIRM/MANUFACTURER
Accuray Inc, Sunnyvale, CA, by Urgent Advisory Notification on March 20, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide and Internationally