Drug recall
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT…
FDA recall event 65848 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 65848 |
|---|---|
| Recall numbers | Z-2095-2013 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 18, 2013 |
| Report date | Sep 4, 2013 |
| Termination date | Nov 24, 2014 |
| City | Martinez |
| State | CA |
| Country | United States |
| FEI number | 2910081 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: