Reported Mar 15, 2023 · Ongoing
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Elekta Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Inc · 1450 Beale St Ste 205 · Saint Charles, MO · 63303
Is this the product you have?
- Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Lot codes and dates
- Software Build
5.11.005.11.015.11.025.11.03
- UDI Numbers
(01)00858164002169(10)5.11.00(01)00858164002169(10)5.11.01(01)00858164002169(10)5.11.02(01)00858164002169(10)5.11.03
- Software Build
- Amount recalled
- 2,020 units
Where it was sold
- Nationwide
- GA
Why it was recalled
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
This product could cause temporary or reversible health problems — stop using it.
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