United StatesRefleXion X1 Radiotherapy System Model RXM1000 (Part #800-00006-00) sold in several US states is affected; units run Software Version 2.1.29-4 or 2.1.35-1 (listed UDIs). The device was recalled because a software defect can fail to carry angular roll corrections through to treatment delivery, potentially displacing the delivered dose by 5 mm or more and causing a 10%–20% underdose.
What's being recalled
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Recalling firm: Reflexion Medical, Inc., Hayward, CA, United States.
How to identify it
Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (01)00860003983812(11)230504(21)X11001, (01)00860003983812(11)230518(21)X11002, (01)00860003983812(11)230505(21)X11003, (01)00860003983812(11)230530(21)X11004, (01)00860003983812(11)230811(21)X11006, (01)00860003983812(11)230410(21)X11007, (01)00860003983812(11)230803(21)X11008, (01)00860003983812(11)240528(21)X11009, (01)00860003983812(11)240820(21)X11010, (01)00860003983812(11)241107(21)X11011, (01)00860003983812(11)241206(21)X11012, (01)00860003983812(11)250731(21)X11013.
The hazard
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
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: CA, TX, PA, CT, NJ, OR, LA, OH
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)