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: Primeview 3i 2.1, Part No. 8147675, Current R640; 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.
This recall has been terminated (originally issued April 2, 2013).
- Recall Initiated
- March 5, 0013
- Posted
- April 2, 2013
- Terminated
- August 28, 2014
- Recall Number
- Z-1043-2013
- Quantity
- 621 units (foreign account) in total
- Firm Location
- Martinez, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution
Lot / Code Info
All units of these models.
Root Cause
Software design (manufacturing process)
Action Taken
Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters". 9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out 10/18/2013; Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released