Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 7/6/2011
Class ll:

PRODUCT
ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; and syngo RT Therapist Connect/MOSAIQ OIS Part number 08168754. The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software. Recall # Z-2243-2011

REASON
Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, letter on March 31, 2011.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
164 active devices

DISTRIBUTION
Nationwide and Internationally