FDA Device recall Z-2812-2015
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist by Siemens Medical Solutions Usa, citing A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2812-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-05 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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.
Reason
A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
Identifiers
| code_info | ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression 07360717 PRIMUS…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2812-2015%22
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