Device product
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
Z-2812-2015
Product summary
- Event
- Event 71915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26
- Official record key
device-enforcement:Z-2812-2015
Official wording
Reason: A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
Code information: ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression 07360717 PRIMUS - K993425 PRIMUS Plus 04504200 Syngo RT Therapist - 08162815 serial numbers: 5177 3761 3981 3998 5096 70-4161 3354 10570 10793 10794 10796 10795 10798 10814 10792 5300 10046 10549 10687 3624 5350 5784 10586 5830 10010 5419
Distribution pattern: Worldwide Distribution and US Nationwide
Derived failure modes
-
Device software or design
software fix has been released to prevent