ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS b...
FDA Device Recall #Z-1562-2013 — Class II — May 29, 2013
Recall Summary
| Recall Number | Z-1562-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 29, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc |
| Location | Martinez, CA |
| Product Type | Devices |
| Quantity | 8 units |
Product Description
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.
Distribution Pattern
Worldwide distribution
Lot / Code Information
All units of the version 4.3, Part No. 08162815
Other Recalls from Siemens Medical Solutions USA, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0786-2014 | Class II | SIMVIEW NT and SIMVIEW NT with IDI: October ... | Dec 11, 2013 |
| Z-0787-2014 | Class II | PRIMUS, ONCOR, ARTISTE Linac systems with compo... | Dec 5, 2013 |
| Z-0438-2014 | Class II | SIEMENS brand ARTISTE Linear Accelerator Linac ... | Oct 23, 2013 |
| Z-0437-2014 | Class II | SIEMENS brand ONCOR series Linear Accelerator L... | Oct 23, 2013 |
| Z-2095-2013 | Class II | PRIMUS, ONCOR, ARTISTE Linac systems with compo... | Jul 18, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.