RayStation/RayPlan- designed for treatment planning and… recallZ-0732-2022 · Raysearch Laboratories AB · initiated Dec 30, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Raysearch Laboratories AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Software design
What the company is doing
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].
Recall details
- Recall number
- Z-0732-2022
- Status
- Open, Classified
- Initiated by the company
- Dec 30, 2021
- Recalling firm
- Raysearch Laboratories AB
- Quantity
- 75 Licenses
- Product code
- MUJ
- FDA submissions
- K211867
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- RayStation 9Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment12 recalls0 reports
- RayStation 8.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 9B SP1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 8.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 7Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment8 recalls0 reports
- RayStation 6.2Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment7 recalls0 reports
- RayStation 6.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment7 recalls0 reports
- RayStation 6.0Raysearch Laboratories AB (Publ) · System,Planning,Radiation Therapy Treatment6 recalls0 reports
Other devices under the same FDA submission
3 devices cleared under K211867 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- RayStation 11.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment8 recalls0 reports
- RayStation 11.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment7 recalls0 reports
- RayStation 11A SP2Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment5 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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