FDA recall Z-1403-2022

Product

RayStation 9B SP1. For radiation treatment planning.

Reason for recall

An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

Distribution

Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.

Key facts

Status

Terminated

Initiation date

2022-06-01

Report date

2022-07-27

Termination date

2023-10-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2022