FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayCare 2024A SP4. Oncology Information Systems.
- Recall number
- Z-2647-2026
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayCare 2024A SP4. Oncology Information Systems.
- Status
- Open, Classified
- Initiated
- 2026-05-20
- Posted
- 2026-07-01
- Terminated
- not on file
- Reason
- Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
- Root cause
- Under Investigation by firm
- Action
- A Field Safety Notice, Medical Device Correction #175428 dated 6/2/26 was emailed to consignees. The notice advises consignees to ensure clear verbal or procedural communication when updating the beam set delivery note, avoid making changes from any location other than the control room when treatment is ongoing, avoid relying on beam set delivery note for conveying critical information. Additionally, consignees are to ensure planning staff and users are educated of the provided workaround. Consignees are to verify the software version of their units and reply to the emailed notification. A software update is scheduled for August 2026 to address this issue. Consignees with questions can contact quality@raysearchlabs.com.
- Quantity
- 3 units
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
- 510(k) numbers
- ["K242992"]
- 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