Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-2324-2012) was formally reported on September 12, 2012, with the manufacturer initiating the action on May 9, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Raysearch Laboratories Ab is listed as the recalling firm, operating out of Stockholm, N/A. Federal records list the affected scope as 19 units.
The documented reason for this recall is: 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 o… Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.. 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
19 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Raysearch Laboratories Ab. Units affected: 19 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2012. Severity: Moderate. Recall number: Z-2324-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2324-2012) 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 September 12, 2012. 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.