United StatesMOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO), MOSAIQ v3.10.200 and versions 3.1.1.0 through 3.2.3.1 with Particle Base (UDI‑DI 07340201500026, 07340201500071) is recalled. It was recalled because, when using the Particle Therapy IHE‑RO TDW‑II interface with one field per fraction or a last-field partial treatment, a partial treatment followed by interruptions and manually recorded partial treatments can lead the treatment unit to miss a meterset check and deliver the partial treatment twice, risking overtreatment.
What's being recalled
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Recalling firm: Elekta, Inc., Atlanta, GA, United States.
How to identify it
MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071
The hazard
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the state of TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)