Siemens Linear Accelerators of type ARTISTE — Class II medical device recall Z-2174-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-08-20, distributed nationwide. A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where
| Recall number | Z-2174-2014 |
|---|---|
| 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 | 2014-05-28 |
| Classified | 2014-08-10 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2015-07-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 160 |
Product
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
Reason for recall
A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
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-2174-2014. 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.