Z-1403-2022 Class II Terminated

Recalled by RAYSEARCH LABORATORIES AB — Stockholm, N/A

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
June 1, 2022
Termination Date
October 4, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

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 Pattern

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

Code Information

UDI-DI: 0735000201029720200310 Build number 9.2.0.483