FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
- Recall number
- Z-0294-2019
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
- Status
- Terminated
- Initiated
- 2018-09-21
- Posted
- not on file
- Terminated
- 2020-06-16
- Reason
- Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
- Root cause
- Software design
- Action
- Ray Search Labs notified userson 9/21/18 by email advising users of the action to be taken: After creating an adaptive plan from a plan with robust objectives, remove all robust objectives that are automatically added to the adaptive plan and replace them with other appropriate objectives before optimizing the adapted plan. o Do not use an optimization function template with robust functions for a dependent beam set.o Do not use scripting to add robust optimization functions related to beam set + background dose. Reply form to be completed/signed and returned. Regulatory information, please contact quality@raysearchlabs.com
- Quantity
- 110 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Software, include version number: 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10, 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 5.0.0.37 , 5.0.1.11 , 5.0.2.3 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19
- 510(k) numbers
- ["K180379"]
- 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