Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/10/2013
Class ll:
PRODUCT
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Recall Number Z-1036-2013
REASON
Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Martinez, CA, on 3/5/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
621 units (foreign account) in total
DISTRIBUTION
Nationwide and Internationally
___________________________________
