Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptio...
FDA Device Recall #Z-0181-2016 — Class II — October 16, 2015
Recall Summary
| Recall Number | Z-0181-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 16, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Elekta, Inc. |
| Location | Atlanta, GA |
| Product Type | Devices |
| Quantity | 154 |
Product Description
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for Recall
Unintended update of Dose and MU and Incorrect Assignment of Bolus.
Distribution Pattern
CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
Lot / Code Information
Software Version 5.10.01
Other Recalls from Elekta, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1581-2026 | Class II | Brand Name: Leksell Gamma Knife Product Descri... | Feb 18, 2026 |
| Z-1164-2026 | Class II | Brand Name: Elekta Medical Linear Accelerator ... | Dec 14, 2025 |
| Z-1339-2026 | Class II | Brand Name: Leksell GammaPlan Product Name: Ra... | Dec 12, 2025 |
| Z-1340-2026 | Class II | Brand Name: Leksell GammaPlan Product Name: Ra... | Dec 12, 2025 |
| Z-1078-2026 | Class II | MOSAIQ Oncology Information System with Particl... | Dec 10, 2025 |
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.