Reported Dec 7, 2016 · Terminated
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. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
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 Builds 5.11 and 5.20
- Amount recalled
- 671
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
Incorrect Dose when using the reset function.
This product could cause temporary or reversible health problems — stop using it.
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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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