Device product

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.

Z-1933-2024

April 16, 2024

Class II

Product summary

Firm: Reflexion Medical, Inc.
Event: Event 94533
Status: Ongoing
Classification: Class II
Quantity: 7 systems
Official record key: device-enforcement:Z-1933-2024

Official wording

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

Code information: 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

Distribution pattern: U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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