Z-1403-2022Class II

RayStation 9B SP1. For radiation treatment planning

Name: Z-1403-2022 RayStation 9B SP1. For radiation treatment planning
Creator: Raysearch Laboratories Ab
Published: 2022-06-01
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2022-06-01 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 9B SP1. For radiation treatment planning on 2022-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1403-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-01
Posted: 2022-07-19
Terminated: 2023-10-04
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 9B SP1. For radiation treatment planning.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
Root cause tag: software
FDA root cause: Software change control
Action: The firm contacted all customers via email on June 1, 2022. Customers were provided with a list of workflows where safety related information may not be propagated. Customers were instructed to be aware that treatment course information in RayCare may not always be up to date. Customers should verify critical information in RayStation or RayTreat before treatment course information in RayCare is used for critical decisions. Customers were asked to identify all installed units with the affected software version numbers. The issue will be resolved in mandatory software updates for RayStation, scheduled for market release in June 2022.
Quantity in commerce: 1
Distribution: Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.
Product codes and lots: UDI-DI: 0735000201029720200310 Build number 9.2.0.483

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1403-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1403-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-19

Product code MUJ

K200569Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2020-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)