Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/30/2011
Class ll:

PRODUCT
Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Recall # Z-1523-2011

REASON
A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on June 29, 2010.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
18 systems

DISTRIBUTION
NC, OH, and the countries of Belgium, Sweden, Germany, Lebanon, Japan, Australia, and Iran