PlainRecalls
FDA Devices Moderate Class II Terminated

RayStation 9B SP1. For radiation treatment planning.

Reported: July 27, 2022 Initiated: June 1, 2022 #Z-1403-2022

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.

Details

Recalling Firm
RAYSEARCH LABORATORIES AB
Units Affected
1
Distribution
Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.
Location
Stockholm, N/A

Frequently Asked Questions

What product was recalled?
RayStation 9B SP1. For radiation treatment planning.. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 1.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 27, 2022. Severity: Moderate. Recall number: Z-1403-2022.