CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report
RayStation/RayPlan recalled by Raysearch Laboratories Ab
Raysearch Laboratories Ab is recalling RayStation/RayPlan. The recall was initiated on 28 Nov 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1108-2026
- FDA event ID
- 98117
- Recalling firm
- Raysearch Laboratories Ab, Stockholm
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Nov 2025
- FDA classified
- 16 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 28 Nov 2025 | Recall initiated by company | |
| 16 Jan 2026 | Classified by FDA | +49 days |
| 28 Jan 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Where it was distributed
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Questions about this recall
Is RayStation/RayPlan recalled?
Yes. Raysearch Laboratories Ab recalled RayStation/RayPlan on 28 Nov 2025. The recall is Class II and its status is Ongoing. Recall number Z-1108-2026.
Why was it recalled?
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Which lots are affected?
UDI: 0735000201076120240508, 0735000201080820241217 GTIN: 07350002010761, 07350002010808 Serial Numbers: 15.1.0.852, 15.2.0.107 Software Revision: RayStation 2024A SP1, RayStation 2024A SP2 Expiration Date: 2030-04-15
Where was it sold?
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Raysearch Laboratories Ab
All 115| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | RayCare 2024A SP4 recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Other | Nationwide |
| Device | CLASS II | RayCare 2024A SP1 recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Other | Nationwide |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Device Malfunction | |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Device Malfunction | |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Device Malfunction |
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| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |