ARTISTE with syngo RT Therapist version 4 — Class II medical device recall Z-1562-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-06-26. The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety
| Recall number | Z-1562-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Martinez, CA, United States |
| Recall initiated | 2013-05-29 |
| Classified | 2013-06-20 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2013-11-26 |
| Quantity | 8 units |
| Reason classes | specification failure |
| Model numbers | 08162815 |
Product
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Reason for recall
The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.
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-1562-2013. 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.