Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 6/22/2011
Class ll:
PRODUCT
ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software. The intended use is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ARTIST Systems include: Therapist Express Basic Part number 08515289; Therapist Express Assist Part number 08515297; syngo RT Therapist Assist Part number 08162807; syngo RT Therapist Part number 08162815; and sysno RT Therapist connect/MPSAOQ OIS Part number 08168754. Recall # Z-2190-2011
REASON
When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 24, 2011.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
228 active devices
DISTRIBUTION
Nationwide and Internationally
