ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
This recall has been terminated (originally issued July 11, 2011).
- Recall Initiated
- May 25, 2011
- Posted
- July 11, 2011
- Terminated
- March 1, 2012
- Recall Number
- Z-2789-2011
- Quantity
- 45 customers with affected configuration in US, 37 customers ROW.
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system
Distribution
Worldwide Distribution - USA including distribution to LA, CA, PA, MA, NE, NJ, DE, WI, NC, NY, WI, MD, FL, KY and to Poland, Netherlands, Ireland, G=Belgium, Germany, New Zealand, P.R. China, Saudi Arabia, Australia, Malaysia, Egypt, Canada, and Spain.
Lot / Code Info
Coherence RT Therapist v2.1x - Part # 10652387; Coherence RT Therapist v2.2x - Part # 10652388.
Root Cause
Software design
Action Taken
Siemens Customers Service group began providing Update Instructions and installing the software update on affected machines beginning May 25, 2011. A customer information letter was also provided.