Reflexion Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1933-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 16, 2024

Date Posted: June 5, 2024

Recall Number: Z-1933-2024

Event ID: 94533

Reason for Recall:

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

Status: Ongoing

Product Quantity: 7 systems

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.

Voluntary or Mandated:

Voluntary: Firm initiated