FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
- Recall number
- Z-1806-2014
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
- Status
- Terminated
- Initiated
- 2014-04-25
- Posted
- 2014-06-17
- Terminated
- 2017-06-26
- Reason
- This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
- Root cause
- Software design
- Action
- On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.
- Quantity
- 25 sites/245 units (US), 25 sites/124 units (foreign)
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
- Lot, serial or model codes
- Software version 4.0.3.4
- 510(k) numbers
- ["K130617"]
- 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