Reflexion Medical, Inc.: 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 tomograph

Hazard

A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

Details from the source

Reason for recall: A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. Distribution: U.S.: CA, CT, NJ, OR, PA and TX No O.U.S. Quantity: 7 systems Lot/code info: 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

UPC codes

00860003983812

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.