Reflexion Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0470-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"

Product Classification:

Class II

Date Initiated: November 24, 2021

Date Posted: January 19, 2022

Recall Number: Z-0470-2022

Event ID: 89212

Reason for Recall:

Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).

Status: Terminated

Product Quantity: 3 devices

Code Information:

Model: RXM1000 Serial Numbers/UDI Codes: X11001 / (01)00860003983805(11)210125(21)X11001 X11002 / (01)00860003983805(11)210324(21)X11002 X11003 / (01)00860003983805(11)210524(21)X11003

Distribution Pattern:

U.S. Nationwide distribution in the states of CA and TX

Voluntary or Mandated:

Voluntary: Firm initiated