FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation 9B SP1. For radiation treatment planning.
- Recall number
- Z-1403-2022
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation 9B SP1. For radiation treatment planning.
- Status
- Terminated
- Initiated
- 2022-06-01
- Posted
- not on file
- Terminated
- 2023-10-04
- Reason
- An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
- Root cause
- Software change control
- Action
- The firm contacted all customers via email on June 1, 2022. Customers were provided with a list of workflows where safety related information may not be propagated. Customers were instructed to be aware that treatment course information in RayCare may not always be up to date. Customers should verify critical information in RayStation or RayTreat before treatment course information in RayCare is used for critical decisions. Customers were asked to identify all installed units with the affected software version numbers. The issue will be resolved in mandatory software updates for RayStation, scheduled for market release in June 2022.
- Quantity
- 1
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.
- Lot, serial or model codes
- UDI-DI: 0735000201029720200310 Build number 9.2.0.483
- 510(k) numbers
- ["K200569"]
- 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