Z-1598-2021Class II

RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B...

Name: Z-1598-2021 RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B...
Creator: Raysearch Laboratories Ab
Published: 2021-04-07
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2021-04-07 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs on 2021-04-07. FDA classified it as Class II and gives the reason as "When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose...". 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-1598-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-07
Posted: 2021-05-14
Terminated: 2023-06-02
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.
Root cause tag: software
FDA root cause: Software design
Action: On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.
Distribution: Domestic: TN
Product codes and lots: Software version number: 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 , 10.1.0.613

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1598-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1598-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-14

Product code MUJ

K200569Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2020-09-24

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)