FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: 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.
- Recall number
- Z-1679-2015
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: 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.
- Status
- Terminated
- Initiated
- 2015-05-08
- Posted
- 2015-05-27
- Terminated
- 2017-04-11
- Reason
- RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
- Root cause
- Software Design Change
- Action
- RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information.
- Quantity
- Domestic: 539 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Software Version (Build numbers) 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, or 4.0.3.4
- 510(k) numbers
- ["K120387","K130617","K140187"]
- 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