Company: Varian Medical Systems Oncology Systems
Date of Enforcement Report 10/8/2008
Class:ll
PRODUCT
Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48, Recall # Z-1612-2008
REASON
A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated February 13, 2008.
Manufacturer: Varian Medical Systems, Finland 04, Helsinki, Finland. Firm initiated recall is ongoing..
VOLUME OF PRODUCT IN COMMERCE
90 units
DISTRIBUTION
Nationwide and Internationally