ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist… — Class II medical device recall Z-2073-2012
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2012-08-01, distributed in FL. Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during th
| Recall number | Z-2073-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Concord, CA, United States |
| Recall initiated | 2012-06-25 |
| Classified | 2012-07-24 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2012-10-18 |
| Distributed | FL |
| Countries outside the US | DE, IN, KR, PL, TH |
| Quantity | 18 |
| Model numbers | 05857912, 05863472, 07360717, 08139789 |
Product
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Reason for recall
Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
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-2073-2012. 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.