Z-1679-2015Class II

RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment

Name: Z-1679-2015 RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment
Creator: Raysearch Laboratories Ab
Published: 2015-05-08
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2015-05-08 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and... on 2015-05-08. FDA classified it as Class II and gives the reason as "RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing". 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-1679-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Posted: 2015-05-27
Terminated: 2017-04-11
Recalling firm: RaySearch Laboratories AB (publ)
Product: RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: 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: RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
Root cause tag: software
FDA root cause: Software Design Change
Action: RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information.
Quantity in commerce: Domestic: 539 units
Distribution: US Nationwide Distribution
Product codes and lots: Software Version (Build numbers) 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, or 4.0.3.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1679-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1679-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-27

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)