Z-0478-2021Class II

RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2...

Name: Z-0478-2021 RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2...
Creator: Raysearch Laboratories Ab
Published: 2020-10-08
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2020-10-08 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product... on 2020-10-08. FDA classified it as Class II and gives the reason as "If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI". 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-0478-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-08
Posted: 2020-11-20
Terminated: 2023-03-30
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.
Root cause tag: software
FDA root cause: Software design
Action: On October 8, 2020, the firm emailed "Field Safety Notice, Medical Device Correction #66704" to affected customers. Customers were made aware of the product issue and asked to take the following actions: " Do not exclude the prescription ROI or POI when exporting from RayStation with the Exclude from export option. " If an RT Structure Set where it is not certain that all referenced bolus and prescription ROIs or POIs are present is imported to RayStation, make sure to check that any intended references to bolus and prescription are correct after import. " Please educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. This issue will be resolved in the next version of RayStation, scheduled for market release in November 2020 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. For regulatory information, please contact [email protected]
Quantity in commerce: 2768
Distribution: US Nationwide distribution.
Product codes and lots: Software version numbers: 4.0.0.14 , 4.0.3.4 , 4.5.1.14 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 ,; 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0478-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0478-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-20

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)