Z-1307-2014Class II

RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system...

Name: Z-1307-2014 RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system...
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 RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of... on 2014-02-06. FDA classified it as Class II and gives the reason as "Potential for dose errors due to software program errors". 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-1307-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-06
Posted: 2014-03-28
Terminated: 2017-02-17
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Potential for dose errors due to software program errors.
Root cause tag: software
FDA root cause: Software Design Change
Action: RaySearch Laboratories sent an Field Safety Notice, Medical Device Correction letter dated February 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. ACTIONS TO BE TAKEN BY THE USER A workaround that eliminates the described error is to select the discard rotations option in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. Another option is to use the ROI based deformable registration when applicable, as this functionality is not affected by the error. SOLUTION This issue will be resolved in a patch release of RayStation, scheduled for market release February 28, 2014. Release schedule is subject to regulatory approval for some markets. In the meantime, this field safety notice is being distributed to all customers. CONTACT INFORMATION For further information, please contact For the Americas: Customer Support, RaySearch Americas, at +1 877 778 3849 For Europe, Asia and rest of the world: RaySearch Laboratories AB, at +46 8 5450 6130 Thank you for your cooperation, and we apologize for any inconvenience
Quantity in commerce: 151 units Total (88 units domestically & 63 units internationally)
Distribution: Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.
Product codes and lots: MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1307-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1307-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-03-28

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)