Z-1317-2012

RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen...

Name: Z-1317-2012 RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen...
Creator: Raysearch Laboratories Ab
Published: 2011-12-06
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2011-12-06 / Terminated / root cause: design

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden... on 2011-12-06. The reason FDA records is "An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient". 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-1317-2012
Status: Terminated
Initiated: 2011-12-06
Posted: 2012-03-26
Terminated: 2012-05-11
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. [email protected] Designed for treatment planning and analysis of radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.
Root cause tag: design
FDA root cause: Device Design
Action: The firm decided to recall and sent Urgent Field Safety Notice Medical Device Correction letters to consignees on 12/06/2011. The letters described the issue, identified the affected product, actions to be taken by the user, a solution, and contact information. Users are to follow the two part workaround, and educate their staff and all users on the workarounds. The letter states that the issue will be resolved in the next version of RayStation. If further information is needed, users are to contact either Freddie Cardel, Director of Customer Support, RaySearch Americas, at 1-877-778-3849 or [email protected]; or Niclas Borglund, Director of Service, RaySearch Laboratories AB, at 46-8-5450-6130 or [email protected]
Quantity in commerce: 21 units (16 domestically and 5 internationally)
Distribution: Worldwide Distribution -- US, including the states of FL, MA, NJ, and NY and the country of the Netherlands.
Product codes and lots: Software version and build number is 2.0.0.15. Model number RayStation 2.0

Product code MUJ

K100552Class IIRaystation Version 1.0Raysearch Laboratories AB / cleared 2010-03-12

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)