Reported Jan 18, 2017 · Terminated
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam…
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 Product UsageUsed to make treatment plans for patients with prescriptions for external beam radiation therapy
- Lot codes and dates
- Software Versions 5.00 and higher
- Amount recalled
- 279
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 Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
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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