FDA recall Z-0470-2022

Product

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

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

Key facts

Status

Terminated

Initiation date

2021-11-24

Report date

2022-01-19

Termination date

2024-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hayward, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0470-2022