Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

FDA Device Recall #Z-2406-2021 — Class II — July 26, 2021

Recall Summary

Recall Number Z-2406-2021
Classification Class II — Moderate risk
Date Initiated July 26, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Elekta Inc
Location Saint Charles, MO
Product Type Devices
Quantity N/A

Product Description

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Reason for Recall

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

Distribution Pattern

Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom

Lot / Code Information

Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10

Other Recalls from Elekta Inc

Recall # Classification Product Date
Z-1233-2023 Class II Monaco RTP System. Used to make treatment ... Feb 28, 2023
Z-2563-2021 Class II Elekta Monaco - Product Usage: used to make tre... Sep 14, 2021
Z-1825-2020 Class II Elekta MONACO RTP Sytem, radiation treatment pl... Apr 16, 2020
Z-1826-2020 Class II Leksell Vantage Stereotactic System. Instrument... Mar 30, 2020
Z-0670-2020 Class II Monaco Radiation Treatment Planning System (RTP... Nov 22, 2019

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.