Drug recall
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE…
FDA recall event 65435 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 65435 |
|---|---|
| Recall numbers | Z-1562-2013 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 29, 2013 |
| Report date | Jun 26, 2013 |
| Termination date | Nov 26, 2013 |
| 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: