Z-1464-2020Class II

RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system

Name: Z-1464-2020 RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Creator: Raysearch Laboratories Ab
Published: 2020-02-20
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2020-02-20 / Terminated

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system on 2020-02-20. FDA classified it as Class II and gives the reason as "There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1464-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-20
Posted: 2020-03-10
Terminated: 2024-11-05
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
FDA root cause: Under Investigation by firm
Action: An Urgent Field Safety Notice, Medical Device Correction notification letter dated 2/19/20 was emailed to the customer. ACTIONS TO BE TAKEN BY THE USER " Either do not use the RayTreat tabletop propagation functionality or make sure to always perform imaging and registration correction before each treatment session. " When using RayTreat in combination with the ProNova machine, do not use the acquired imaging positions in the preparation tab as the truth about where an image was actually taken. Please educate all users including the planning, Quality Assurance and plan delivery staff about this workaround. Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation, scheduled for market release in March 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. TRANSMISSION OF THIS NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as any version of RayStation affected by this issue is in use to ensure effectiveness of the workaround.
Quantity in commerce: 1 system in the U.S.
Distribution: The products were distributed to the following US states: TN
Product codes and lots: UDI 07350002010129

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1464-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1462-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10
Z-1463-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10
Z-1464-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10
Z-1465-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10
Z-1466-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10
Z-1467-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10
Z-1468-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10

Product code MUJ

K190387Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2019-06-19

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)