FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
- Recall number
- Z-1310-2015
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
- Status
- Terminated
- Initiated
- 2015-03-04
- Posted
- 2015-03-20
- Terminated
- 2017-09-20
- Reason
- An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
- Root cause
- Under Investigation by firm
- Action
- The firm, Raysearch Laboratories, sent a "Medical Device Correction/Field Safety Notice" and Reply Form(dated 3/3/2015) on 3/4/2015 via e-mail to the affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to deprecate any beam models that have been commissioned as DMLC capable for the affected linac types; do not commission beam models as DMLC capable for the affected linac types; educate physics staff and all users; inspect your system and identify all affected units of RayStation, acknowledge this notice by email or complete and return the Reply Form via fax to Americas market, RaySearch Americas Inc., at 888 501 7195, email: freddie.cardel@raysearchlabs.com or Rest of the world, RaySearch Laboratories AB, to email support@raysearchlabs.com. If you have any questions, contact Quality and Regulatory Affairs Manager, at +46 722 366 110 or email david.hedfors@raysearchables.com.
- Quantity
- Domestic: 245 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Build numbers 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14 and 4.7.0.15
- 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