Reported May 6, 2020 · Ongoing
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to…
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?
- Elekta MONACO RTP Sytem, radiation treatment planning
- software system - Product UsageThe Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
- Lot codes and dates
- Software Build5.40.00 (UDI: (01)00858164002190(10) 5.40.00), 5.40.01 (UDI: 01)00858164002190(10) 5.40.01)
- Amount recalled
- 96 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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