Z-1308-2014Class II

RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software

Name: Z-1308-2014 RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Creator: Raysearch Laboratories Ab
Published: 2014-02-06
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2014-02-06 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software on 2014-02-06. FDA classified it as Class II and gives the reason as "RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy". 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-1308-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-06
Posted: 2014-03-31
Terminated: 2017-02-17
Recalling firm: RaySearch Laboratories AB (publ)
Product: RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Root cause tag: software
FDA root cause: Software Design Change
Action: On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases. For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or [email protected].
Quantity in commerce: 19 units (16 units domestically & 3 units internationally)
Distribution: OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
Product codes and lots: Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1308-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1308-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-03-31

Product code MUJ

K130617Class IIRaystationRaysearch Laboratories AB / cleared 2013-05-10

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)