Company: Respironics Novametrix, Inc
Date of Enforcement Report: 7/14/04
Class: II
PRODUCT
Linear accelerator workstation software suite. Recall # Z-1084-04.
REASON
An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1.
CODE
MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by telephone beginning May 27, 2004 and by letters on June 3, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
155 units.
DISTRIBUTION
Nationwide and Internationally.