Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
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 cont…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Raysearch Laboratories Ab recalled Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 S… - a moderate-severity action.
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 S… was recalled by Raysearch Laboratories Ab in January 28, 2026. Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of…. Check the official notice for the remedy. Verify recall #Z-1107-2026 with the FDA Devices before acting.
The recall
Raysearch Laboratories Ab issued this moderate-severity FDA Devices recall-Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of….
- Moderate
- severity level
- Class II
- classification
- January 28, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1107-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1107-2026) was formally reported on January 28, 2026, with the manufacturer initiating the action on November 28, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Raysearch Laboratories Ab is listed as the recalling firm, operating out of Stockholm. Federal records list the affected scope as 0.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
0
Related Recalls
6
3 from same agency
Product description
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1107-2026 |
| Date reported | January 28, 2026 |
| Date initiated | November 28, 2025 |
| Recalling firm | Raysearch Laboratories Ab |
| Firm location | Stockholm |
| Affected scope | 0 |
| Distribution | Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1107-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No. Recalled by Raysearch Laboratories Ab. Units affected: 0.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 28, 2026. Severity: Moderate. Recall number: Z-1107-2026.
Where was the recalled product distributed? ▼
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1107-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 28, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.