FDA Devices recall · Reported September 12, 2012
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system
The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other inci…
Raysearch Laboratories Ab recalled Brand name: RayStation. Generic name: Treatment Planning System. Software version and … - a moderate-severity action.
Brand name: RayStation. Generic name: Treatment Planning System. Software version and … was recalled by Raysearch Laboratories Ab in September 12, 2012. Reason: The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.…. Check the official notice for the remedy. Verify recall #Z-2324-2012 with the FDA Devices before acting.
The recall
Raysearch Laboratories Ab issued this moderate-severity FDA Devices recall-The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.….
- Moderate
- severity level
- 19 units
- affected scope
- Class II
- classification
- September 12, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2324-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Reason for recall
The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2324-2012 |
| Date reported | September 12, 2012 |
| Date initiated | May 9, 2012 |
| Recalling firm | Raysearch Laboratories Ab |
| Firm location | Stockholm, N/A |
| Affected scope | 19 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland. |
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-2324-2012) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026