ARTISTE — Class II medical device recall Z-2812-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-09-30, distributed nationwide. A software fix has been released to prevent automatic movement resulting in a collision safety risk for patien
| Recall number | Z-2812-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2015-08-05 |
| Classified | 2015-09-23 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2016-09-01 |
| Distributed | Nationwide (US) |
| Quantity | 26 |
| Reason classes | software |
| Serial numbers | 10010, 10046, 10549, 10570, 10586, 10687, 10792, 10793, 10794, 10795, 10796, 10798, 10814, 3354, 3624, 3761, 3981, 3998, 5096, 5177, 5300, 5350, 5419, 5784, 5830 and 1 more |
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 for recall
A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2812-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.