Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 179 active devices. |
| Distribution | Worldwide Distribution - USA Nationwide in the states of NJ, IN, PA, FL, OH, MN, MO, CA, AL, NE MI, LA. and countries of:Argentina, China, South Africa, Pakistan, Spain, Switzerland, Italy, Algeria, Croatia, Turkey, Canada, Germany, France, Poland, Japan, Russian Federation. Lebanon, Egypt, Slovakia, Latvia, Kenya, Brazil, Kuwait, Saudi Arabia, Greece, Belgium, Taiwan, Portugal. |
| Initiated | 2013-07-18 |
| Classified | 2013-08-26 |
| Terminated | 2014-11-24 |
| Recall number | Z-2095-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-2095-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65848/
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