FDAFDA · Food and drugs·Recall number Z-1933-2024
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
Published June 5, 2024 · Recall initiated: April 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Reflexion Medical, Inc.
- Distributor
- U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
- Lot
- Model Number: RXM1000 UDI Codes that includes system serial numbers: (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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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