Z-2785-2015Class II

Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment...

Name: Z-2785-2015 Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment...
Creator: Raysearch Laboratories Ab
Published: 2015-05-29
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2015-05-29 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The... on 2015-05-29. FDA classified it as Class II and gives the reason as "An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images". 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-2785-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-09-17
Terminated: 2017-03-13
Recalling firm: RaySearch Laboratories AB (publ)
Product: Radiation Therapy Treatment Planning System software 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
Root cause tag: software
FDA root cause: Software design
Action: The firm, RaySearch Laboratories, distributed a "Field Safety Notice, Medical Device Correction #7106" notice dated May 29, 2015,and reply forms to their customers via email. The notice describes the product, problem and actions to be taken. The Customers were provided a workaround as a temporary fix. Customers were also instructed to educate all users, inspect your product and identify all installed units, confirm you have read and understood the notice by contacting Quality and Regulatory Affairs Manager; and complete and return the reply form via email to [email protected] or by fax to 888-501-7195. The solution will be resolved in the next version of RayStation, scheduled for release in June 2015. Customers were advised to share the notice to all those who need to be aware within the organizations. Customers can contact Quality and Regulatory Affairs Manager at +46 8 510 530 12 or via email at [email protected].
Quantity in commerce: 20 devices
Distribution: Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.
Product codes and lots: software build numbers are 4.7.0.15 or 4.7.1.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2785-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2785-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-17

Product code MUJ

K141860Class IIRaystationRaysearch Laboratories AB / cleared 2014-10-23

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)