Monaco recallZ-2561-2019 · Elekta Inc · initiated Sep 4, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
FDA root cause category: Software design
What the company is doing
The firm notified their consignees of the issue by email on 09/04/2019. The letter explained the problem and the workaround and requested the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and that all appropriate personnel working with the product be advised of the content of the letter.
Recall details
- Recall number
- Z-2561-2019
- Status
- Open, Classified
- Initiated by the company
- Sep 4, 2019
- Recalling firm
- Elekta Inc
- Quantity
- 49 units
- Product code
- MUJ
- FDA submissions
- K190178
- Distribution
- Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
Product description
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
Code information (models, lots, serial numbers)
UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 83692).
- Z-2560-2019 · Open, ClassifiedMonaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external be…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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