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High risk Medical DevicesClass II

RayCare 2024A SP1 Oncology Software Recall

RayCare 2024A SP1. Oncology Information Systems.

Updated May 20, 2026

RayCare 2024A SP1 oncology software can lose patient treatment data if beam set delivery notes are edited at the same time or changed during an active treatment session. Users may not be alerted to these changes, risking incorrect or incomplete treatment records.

Is the RAYSEARCH LABORATORIES AB recalled? Yes. This product was recalled by FDA on May 20, 2026. Details below.

What is recalled

RayCare 2024A SP1 Oncology Information Systems software by RaySearch Laboratories AB.

Am I affected

You're affected if your hospital or cancer treatment facility uses RayCare 2024A SP1 oncology planning or treatment delivery software.

What to do right now

Contact your RaySearch Laboratories account representative or IT administrator immediately to discuss the data loss issue and obtain a software update or patch. Do not rely on beam set delivery notes that may have been modified during or immediately after treatment sessions until you've received guidance from RaySearch.

The hazard

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.

Brands affected

RAYSEARCH LABORATORIES AB
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2646-2026
Classification
Class II
Recalled
May 20, 2026
Read the official notice

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