FDA Device recall Z-2457-2015
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning by Raysearch Laboratories Ab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2457-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-27 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | CO, IL, MI, NC, OH, TN, WA |
Product
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
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.
Identifiers
| code_info | software build numbers are 4.7.1.10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2457-2015%22
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