Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/14/12
Class ll:
PRODUCT
ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. The indication is to deliver X-ray, photon and electron radiation for the therapeutic treatment of cancer. Syngo RT Therapist v4.1, part number 8162815; Syngo RT Therapist Assist (off line system), part number 8162807; Syngo RT Express Basic (stand alone system), part number 8151289; and Syngo RT Express Assist (offline system), part number 8151297. Recall # Z-1092-2012
REASON
Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning January 22, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
182 active devices
DISTRIBUTION
Nationwide and Internationally
