Home / Recalls / Reflexion Medical, Inc. / Z-0470-2022

Z-0470-2022 Class II Terminated

Recalled by Reflexion Medical, Inc. — Hayward, CA

Recall Details

Product Type: Devices
Report Date: January 19, 2022
Initiation Date: November 24, 2021
Termination Date: July 8, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 devices

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"

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).

Distribution Pattern

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

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