Reported Oct 2, 2019 · Ongoing
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make…
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 · 13723 Riverport Dr Ste 100 · Maryland Heights, MO · 63043-4819
Is this the product you have?
- Monaco RTP System, 5.50/5.51, radiation
- treatment planning system Product UsageThe Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning
- It uses generally accepted methods for-contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
- Lot codes and dates
- UDI(01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00
- Amount recalled
- 49 units
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
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
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.
Free recall alerts
Get alerted about new Elekta Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.