Z-0732-2022Class II

RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version...

Name: Z-0732-2022 RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version...
Creator: Raysearch Laboratories Ab
Published: 2021-12-30
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2021-12-30 / Open, Classified / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6... on 2021-12-30. FDA classified it as Class II and gives the reason as "If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0732-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-30
Posted: 2022-03-08
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 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 . Including Service Paks: Product name (build number) UDI-DI RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running
Root cause tag: software
FDA root cause: Software design
Action: RaySearch issued Field Safety Notice, Medical Device Correction #90375 via E-mail, on 30 December 2021. Letter stated reason for recall, health risk and action to take: Do not change the primary image set while the cine loop is running. " If the primary image set has been changed while the cine loop is running, restart RayStation/RayPlan to restore correct behavior. " 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. Solution. This issue is resolved in RayStation/RayPlan versions 10A and higher (subject to market clearance in somemarkets). If customers wish to continue using versions of RayStation/RayPlan 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. Please confirm that you have received this FSN. If you want to attach a signed reply form to the email, please fill in the below. You can also fax this form to Fax: +1-631-828-2137 (US only). For regulatory information, please contact [email protected].
Quantity in commerce: 75 Licenses
Distribution: US Nationwide distribution.
Product codes and lots: Software: 6.0.0.24, 6.1.0.26, 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 UDI: 07350002010013 07350002010082 07350002010075 07350002010242 07350002010068 07350002010112 07350002010136 07350002010129 07350002010204 07350002010235 07350002010174 07350002010266 07350002010297 07350002010013 07350002010082 07350002010075 07350002010242 07350002010068

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0732-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0732-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-08

Product code MUJ

K211867Class IIRayStation 11.0RaySearch Laboratories AB (PUBL) / cleared 2021-09-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)