FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: 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.
- Recall number
- Z-2457-2015
- Recalling firm
- RAYSEARCH LABORATORIES AB
- 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.
- Status
- Terminated
- Initiated
- 2015-05-27
- Posted
- 2015-08-25
- Terminated
- 2017-09-22
- 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.
- Root cause
- Software design
- Action
- On May 27, 2015 RaySearch Laboratories distributed Medical Device Correction notices to their customers via courier service. Within the Medical Device Correction notice, RaySearch Laboratories included a workaround to the problem for their customers. Customers should not use structure templates containing derived ROI definitions with non-uniform contractions. They should avoid using non-uniform contractions. In the case non-uniform contractions must be used, enter switched distances manually and review the result carefully before using it for treatment planning. Lastly, do not use humerus shielding in Automatic Breast Planning. Customers are also expected to complete and return the lower portion of the correction notice via fax to 888-501-7195. **CAPA** Correct the software problem in patch version 4.7.2 of RayStation 4.7, scheduled for market release June 2015.
- Quantity
- 126 programs
- Distribution
- Distributed in CO, IL, MI, NC, OH,TN, and WA.
- Lot, serial or model codes
- software build numbers are 4.7.1.10
- 510(k) numbers
- ["K141860"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 3007774465
- Firm city
- Stockholm
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28