FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
- Recall number
- Z-0679-2019
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
- Status
- Terminated
- Initiated
- 2018-11-12
- Posted
- not on file
- Terminated
- 2020-04-17
- Reason
- Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
- Root cause
- Under Investigation by firm
- Action
- RayStation issued Field Safety Notice, Medical Device Correction #37483, on 11/12/18 via email, states issue, action to be taken and correction of software in Dec 2018.
- Quantity
- 69
- Distribution
- AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI
- Lot, serial or model codes
- Software version number: 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 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 6.0.0.24 , 6.1.0.26, 6.1.1.2 , 6.2.0.7 , 7.0.0.19 , 8.0.0.61 or 8.0.1.10
- 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