Monaco recallZ-0670-2020 · Elekta Inc · initiated Nov 22, 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
Monaco is using the incorrect energy when optimizing and calculating dose.
FDA root cause category: Software Design Change
What the company is doing
An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions.
Recall details
- Recall number
- Z-0670-2020
- Status
- Open, Classified
- Initiated by the company
- Nov 22, 2019
- Recalling firm
- Elekta Inc
- Quantity
- 76 (7 US, 69 OUS)
- Product code
- MUJ
- FDA submissions
- K183037, K190178
- Distribution
- IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Product description
Monaco Radiation Treatment Planning System (RTP) System
Code information (models, lots, serial numbers)
Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
Product lines
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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