PRIMUS — Class II medical device recall Z-2095-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-09-04, distributed nationwide. Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment ta
| Recall number | Z-2095-2013 |
|---|---|
| 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 | 2013-07-18 |
| Classified | 2013-08-26 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-11-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, BR, CA, CH, CN, DE, DZ, EG, ES, FR, GR, HR, IT, JP, KE, KW, LB, LV, PK, PL, PT, SA, SK, TR, TW, ZA |
| Quantity | 179 active |
| Reason classes | device malfunction |
Product
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE , ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Reason for recall
Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off.
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-2095-2013. 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.