Z-0281-2014Class II

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

Name: Z-0281-2014 Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Creator: Raysearch Laboratories Ab
Published: 2013-10-23
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2013-10-23 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 on 2013-10-23. FDA classified it as Class II and gives the reason as "Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees". 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-0281-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Posted: 2013-11-14
Terminated: 2017-02-17
Recalling firm: RaySearch Laboratories AB (publ)
Product: Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
Root cause tag: software
FDA root cause: Software design
Action: Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
Quantity in commerce: 195 units domestically
Distribution: US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
Product codes and lots: Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0281-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0281-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14

Product code MUJ

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)