Z-1310-2015Class II

RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and...

Name: Z-1310-2015 RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and...
Creator: Raysearch Laboratories Ab
Published: 2015-03-04
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2015-03-04 / Terminated

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue... on 2015-03-04. FDA classified it as Class II and gives the reason as "An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1310-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-04
Posted: 2015-03-20
Terminated: 2017-09-20
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
FDA root cause: Under Investigation by firm
Action: The firm, Raysearch Laboratories, sent a "Medical Device Correction/Field Safety Notice" and Reply Form(dated 3/3/2015) on 3/4/2015 via e-mail to the affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to deprecate any beam models that have been commissioned as DMLC capable for the affected linac types; do not commission beam models as DMLC capable for the affected linac types; educate physics staff and all users; inspect your system and identify all affected units of RayStation, acknowledge this notice by email or complete and return the Reply Form via fax to Americas market, RaySearch Americas Inc., at 888 501 7195, email: [email protected] or Rest of the world, RaySearch Laboratories AB, to email [email protected]. If you have any questions, contact Quality and Regulatory Affairs Manager, at +46 722 366 110 or email [email protected].
Quantity in commerce: Domestic: 245 units
Distribution: Nationwide Distribution.
Product codes and lots: Build numbers 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14 and 4.7.0.15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1310-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1310-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-20

Product code MUJ

K141860Class IIRaystationRaysearch Laboratories AB / cleared 2014-10-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)