Z-0720-2017Class II

Radiation Therapy Treatment Planning System

Name: Z-0720-2017 Radiation Therapy Treatment Planning System
Creator: Raysearch Laboratories Ab
Published: 2016-10-11
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2016-10-11 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy... on 2016-10-11. FDA classified it as Class II and gives the reason as "An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the...". 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-0720-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-11
Posted: 2016-12-07
Terminated: 2019-06-11
Recalling firm: RaySearch Laboratories AB (publ)
Product: Radiation Therapy Treatment Planning System 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.
Root cause tag: software
FDA root cause: Software design
Action: On October 11, 2016 RaySearch Laboratories distributed a Field Safety Notice, Medical Device Correction #13529 to customers via email. Customers were instructed to take caution when a patient has multiple cases. The following may be incorrect if there are image sets that shre the same Frame of Reference residing in different cases: *Display of evaluation dose computed on another CT image set and *Dose tracking fraction dose and deformed dose. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. In these cases, the display of the dose values in the 2D view, including the dose value shown when pointing in the view, maximum dose position, dynamic isodose lines and dose grid display may be incorrect. Customers are encouraged to educate staff and all users about this. For regulatory information, please contact David Hedfors, at +46 8 510 530 12 or [email protected].
Quantity in commerce: 540 units
Distribution: US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & WA
Product codes and lots: Build No: "5.0.0.37, 5.0.1.11 or 5.0.2.35. Only 5.0.2.35 was distributed in the U.S.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0720-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0720-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-07

Product code MUJ

K160093Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2016-04-08

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)