Z-1806-2014Class II

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and...

Name: Z-1806-2014 RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and...
Creator: Raysearch Laboratories Ab
Published: 2014-04-25
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2014-04-25 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy on 2014-04-25. FDA classified it as Class II and gives the reason as "This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume...". 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-1806-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-25
Posted: 2014-06-17
Terminated: 2017-06-26
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation software version 4.0.3.4 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: This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Root cause tag: software
FDA root cause: Software design
Action: On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.
Quantity in commerce: 25 sites/245 units (US), 25 sites/124 units (foreign)
Distribution: Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
Product codes and lots: Software version 4.0.3.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1806-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1806-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16

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)