FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
- Recall number
- Z-1427-2021
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
- Status
- Open, Classified
- Initiated
- 2021-03-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
- Root cause
- Under Investigation by firm
- Action
- On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat.
- Quantity
- 1 system
- Distribution
- US Nationwide in the state of TN.
- Lot, serial or model codes
- Software version: 9A, 9B, 10A, 10B
- 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