Home / Recalls / Reflexion Medical, Inc. / Z-1933-2024

Z-1933-2024 Class II Ongoing

Recalled by Reflexion Medical, Inc. — Hayward, CA

Recall Details

Product Type: Devices
Report Date: June 5, 2024
Initiation Date: April 16, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7 systems

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.

Reason for Recall

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

Distribution Pattern

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

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