Z-0294-2019Class II

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment...

Name: Z-0294-2019 RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment...
Creator: Raysearch Laboratories Ab
Published: 2018-09-21
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2018-09-21 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system on 2018-09-21. FDA classified it as Class II and gives the reason as "Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7". 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-0294-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-21
Posted: 2018-10-30
Terminated: 2020-06-16
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Root cause tag: software
FDA root cause: Software design
Action: Ray Search Labs notified userson 9/21/18 by email advising users of the action to be taken: After creating an adaptive plan from a plan with robust objectives, remove all robust objectives that are automatically added to the adaptive plan and replace them with other appropriate objectives before optimizing the adapted plan. o Do not use an optimization function template with robust functions for a dependent beam set.o Do not use scripting to add robust optimization functions related to beam set + background dose. Reply form to be completed/signed and returned. Regulatory information, please contact [email protected]
Quantity in commerce: 110 units
Distribution: Nationwide
Product codes and lots: Software, include version number: 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10, 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 5.0.0.37 , 5.0.1.11 , 5.0.2.3 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0294-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0294-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-30

Product code MUJ

K180379Class IIRayStation 7RaySearch Laboratories AB (PUBL) / cleared 2018-04-25

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)