FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation 11B
- Recall number
- Z-1299-2022
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation 11B
- Status
- Terminated
- Initiated
- 2022-06-10
- Posted
- not on file
- Terminated
- 2024-06-11
- Reason
- This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
- Root cause
- Under Investigation by firm
- Action
- The firm notified customers of the recall via email on June 10, 2022. The notice was titled "Field Safety Notice, Medical Device Correction #99834." Customers were given precautions and instructed on a workaround. The issue will be resolved in the next version of RayStation, scheduled for market release in June 2022, though this may be subject to market clearance.
- Quantity
- 26
- Distribution
- US Nationwide distribution in the states of NJ and TX.
- Lot, serial or model codes
- UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68
- 510(k) numbers
- ["K220141"]
- 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