FDA recall Z-1933-2024

Product

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

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

Key facts

Status

Ongoing

Initiation date

2024-04-16

Report date

2024-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hayward, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1933-2024