Z-2324-2012Class II

Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are...

Name: Z-2324-2012 Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are...
Creator: Raysearch Laboratories Ab
Published: 2012-05-09
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2012-05-09 / Terminated / root cause: design

FDA source

RAYSEARCH LABORATORIES AB began a recall of Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years... on 2012-05-09. FDA classified it as Class II and gives the reason as "The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2324-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-09
Posted: 2012-09-06
Terminated: 2013-01-25
Recalling firm: RaySearch Laboratories AB (publ)
Product: Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio
Root cause tag: design
FDA root cause: Device Design
Action: The firm, RaySearch Laboratories, sent an "Urgent Field Safety Notice, Medical Device Correction" letter dated May 9, 2012 to its customers. The letter describes the product, problem and actions to be taken. The letter informed the customers that the "workaround is to not use segment MU optimization" and that there "is in general no need to manually adjust the segment shapes to such an extent there is need for a separate optimization of the segment MU." Additionally, the customers were instructed -Do not uncheck the "Segment shapes" check box; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the noted software version numbers; and complete and return the Reply Form via fax to: RaySearch Americas Inc. at 888-501-7195; email: [email protected] and/or email to: Raysearch Laboratories AB at [email protected]. For further information and return of the Reply Form contact For the Americas: Director of Customer Support, RaySearch Americas at +1877 778 3849 or [email protected]; and For Europe, Asia and rest of the world: Director of Service, RaySearch Laboratories AB at +46 8 5450 6130 or [email protected].
Quantity in commerce: 19 units
Distribution: Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.
Product codes and lots: Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2324-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2324-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

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)