Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 2, 2015
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, i…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Raysearch Laboratories Ab recalled RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Plannin… - a moderate-severity action.
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Plannin… was recalled by Raysearch Laboratories Ab in September 2, 2015. Reason: Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are use…. Check the official notice for the remedy. Verify recall #Z-2457-2015 with the FDA Devices before acting.
The recall
Raysearch Laboratories Ab issued this moderate-severity FDA Devices recall-Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are use….
- Moderate
- severity level
- Class II
- classification
- September 2, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2457-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2457-2015) was formally reported on September 2, 2015, with the manufacturer initiating the action on May 27, 2015. 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 126 programs.
The documented reason for this recall is: Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior.… Distribution data in the federal record shows the product reached: Distributed in CO, IL, MI, NC, OH,TN, and WA.. 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
126 programs
Related Recalls
6
3 from same agency
Product description
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Reason for recall
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2457-2015 |
| Date reported | September 2, 2015 |
| Date initiated | May 27, 2015 |
| Recalling firm | Raysearch Laboratories Ab |
| Firm location | Stockholm, N/A |
| Affected scope | 126 programs |
| Distribution | Distributed in CO, IL, MI, NC, OH,TN, and WA. |
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-2457-2015) 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 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.. Recalled by Raysearch Laboratories Ab. Units affected: 126 programs.
Why was this product recalled? ▼
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2457-2015.
Where was the recalled product distributed? ▼
Distribution: Distributed in CO, IL, MI, NC, OH,TN, and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2457-2015) 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 2, 2015. 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.