Z-1419-2013Class II

RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System...

Name: Z-1419-2013 RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System...
Creator: Raysearch Laboratories Ab
Published: 2013-02-15
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2013-02-15 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation... on 2013-02-15. FDA classified it as Class II and gives the reason as "Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during...". 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-1419-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-15
Posted: 2013-05-28
Terminated: 2017-02-17
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. 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: Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Root cause tag: software
FDA root cause: Software change control
Action: RaySearch Laboratories sent an Urgent Field Safety Notice, Medical Device Correction letter dated January 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to educate their planning staff and all users about the recommended workarounds contained in the letter. Customers were also asked to inspect their product and identify all installed units that were infected and then complete the attached Reply Form and e-mail or scan a copy of the completed form to the firm. Customers were instructed to pass along this information to all those who need to be aware of this Medical Device Correction Customers with questions were instructed to contact the RaySearch support email at support@raysearchlabs. For questions regarding this recall call +46 8 545 06130.
Quantity in commerce: Domestic: 70 units; Foreign: 27 units
Distribution: Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
Product codes and lots: Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1419-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1419-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-28

Product code MUJ

K120387Class IIRaystationRaysearch Laboratories AB / cleared 2012-04-06

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)