FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
- Recall number
- Z-1930-2019
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
- Status
- Terminated
- Initiated
- 2017-11-20
- Posted
- not on file
- Terminated
- 2023-08-08
- Reason
- When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
- Root cause
- Software design
- Action
- RaySearch issued Field Safety Notice, Medical Device Correction #24138 via email on November 20th, 2017. The letter identifies the product, issue, health risk and action to take: Do not use a number of histories above 6 million for electron dose calculation. Inspect all commissioned electron beam models for any applicator calculated with greater than 6 million. Contact customer support if you have any further questions. Confirm you have read and understood this notice. This issue will be resolved in the next version of RayStation, scheduled for market release in December 2017. Educate planning staff and all users about this workaround.
- Quantity
- 744
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Software versions: 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 , 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 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 and 6.2.0.7
- 510(k) numbers
- ["K171536"]
- 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