Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 29, 2023
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Raysearch Laboratories Ab recalled Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9… - a moderate-severity action.
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9… was recalled by Raysearch Laboratories Ab in March 29, 2023. Reason: It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct…. Check the official notice for the remedy. Verify recall #Z-1281-2023 with the FDA Devices before acting.
The recall
Raysearch Laboratories Ab issued this moderate-severity FDA Devices recall-It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct….
- Moderate
- severity level
- Class II
- classification
- March 29, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1281-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1281-2023) was formally reported on March 29, 2023, with the manufacturer initiating the action on February 17, 2023. 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, N/A. Federal records list the affected scope as 10770 systems.
The documented reason for this recall is: It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not… Distribution data in the federal record shows the product reached: US Nationwide. 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
10770 systems
Related Recalls
6
3 from same agency
Product description
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs
Reason for recall
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1281-2023 |
| Date reported | March 29, 2023 |
| Date initiated | February 17, 2023 |
| Recalling firm | Raysearch Laboratories Ab |
| Firm location | Stockholm, N/A |
| Affected scope | 10770 systems |
| Distribution | US Nationwide |
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-1281-2023) 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? ▼
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs. Recalled by Raysearch Laboratories Ab. Units affected: 10770 systems.
Why was this product recalled? ▼
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2023. Severity: Moderate. Recall number: Z-1281-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1281-2023) 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 March 29, 2023. 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.