Z-2646-2026Class II

RayCare 2024A SP1. Oncology Information Systems

Name: Z-2646-2026 RayCare 2024A SP1. Oncology Information Systems
Creator: Raysearch Laboratories Ab
Published: 2026-05-20
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2026-05-20 / Open, Classified

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayCare 2024A SP1. Oncology Information Systems on 2026-05-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2646-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-20
Posted: 2026-07-01
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayCare 2024A SP1. Oncology Information Systems.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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.
FDA 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 [email protected].
Quantity in commerce: 3 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2646-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2646-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2647-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code MUJ

K242992Class IIRayCare (2024A SP1)RaySearch Laboratories AB (PUBL) / cleared 2025-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)