Z-2039-2023Class II

Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B...

Name: Z-2039-2023 Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B...
Creator: RaySearch America Inc
Published: 2021-01-22
License: https://open.fda.gov/license/

RaySearch Americas Inc. / initiated 2021-01-22 / Terminated / root cause: software

FDA source

RaySearch America Inc began a recall of Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B... on 2021-01-22. FDA classified it as Class II and gives the reason as "A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If 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-2039-2023
Classification: Class II
Status: Terminated
Initiated: 2021-01-22
Posted: 2023-06-29
Terminated: 2023-07-03
Recalling firm: RaySearch Americas Inc.
Product: Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.
Root cause tag: software
FDA root cause: Software design
Action: Field Safety Notice 73474 was emailed January 22, 2021 to affected customers. The notice identifies affected RayStation models: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B running software versions RS 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Users are instructed not to use Create wall, Expand/Contract, or ROI algebra functions directly on ROIs created by the DL segmentation. Instead, convert the ROIs to contour or mesh representation before using the affected functions. Users are to confirm they read and understood the notice by replying to the email. Error fixed in RS 10B Service Pack 1 and corrected in the next version of RayStation.
Quantity in commerce: 5 systems
Distribution: US: AZ, CA, GA & WA
Product codes and lots: UDI-DI: 07350002010129 UDI-DI: 07350002010204 UDI-DI: 07350002010235 UDI-DI: 07350002010174 UDI-DI: 07350002010266 UDI-DI: 07350002010297 UDI-DI: 07350002010303 UDI-DI: 07350002010365 UDI-DI: 07350002010310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2039-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2039-2023	Class II	Terminated	Voluntary: Firm initiated	2023-07-05	2023-06-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)