FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
- Recall number
- Z-1463-2020
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
- Status
- Terminated
- Initiated
- 2020-02-20
- Posted
- not on file
- Terminated
- 2024-11-05
- Reason
- There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Field Safety Notice, Medical Device Correction notification letter dated 2/19/20 was emailed to the customer. ACTIONS TO BE TAKEN BY THE USER " Either do not use the RayTreat tabletop propagation functionality or make sure to always perform imaging and registration correction before each treatment session. " When using RayTreat in combination with the ProNova machine, do not use the acquired imaging positions in the preparation tab as the truth about where an image was actually taken. Please educate all users including the planning, Quality Assurance and plan delivery staff about this workaround. Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation, scheduled for market release in March 2020 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. TRANSMISSION OF THIS NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as any version of RayStation affected by this issue is in use to ensure effectiveness of the workaround.
- Quantity
- 1 system in the U.S.
- Distribution
- The products were distributed to the following US states: TN
- Lot, serial or model codes
- UDI 07350002010136
- 510(k) numbers
- ["K190387"]
- 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