Reported Sep 8, 2021 · Ongoing
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
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 SystemSoftware Builds 5.40.005.40.015.40.02and 5.51.10
- Lot codes and dates
- Software Builds
5.40.005.40.015.40.025.51.10
- UDI(01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10
- Software Builds
- Amount recalled
- N/A
Where it was sold
Why it was recalled
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
This product could cause temporary or reversible health problems — stop using it.
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