Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/4/12
Class ll:
PRODUCT
MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Recall # Z-1270-2012
REASON
Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letters on April 14, 2012.
Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
44 active devices
DISTRIBUTION
Nationwide and Internationally
