The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2647-2026·Announced 2026-07-08

RayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss

RayCare 2024A SP4 oncology information system may lose data or fail to notify users when beam set delivery notes are modified simultaneously or updated during treatment sessions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as Class II. The source describes potential data loss in a medical device used for oncology treatment planning without reporting any illnesses or injuries. This is a risk-of-harm product affecting critical treatment information where injury has not yet been reported, meeting High severity criteria.

Plain-English summary

RAYSEARCH LABORATORIES AB is recalling RayCare 2024A SP4, an Oncology Information System (Software Version 8.0.4.60077). The system has a flaw in beam set delivery note handling that can result in potential data loss if a beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session.

When this issue occurs, users are not notified of the change, which may prevent them from being aware that data has been lost or that modifications have been made to treatment-related information.

Affected units include 3 systems with UDI 0735000201089120241218 distributed worldwide, including US nationwide distribution. The product expiration date is 2030-01-24. Customers should contact RAYSEARCH LABORATORIES AB for guidance on remediation or system updates.

The recalled product

Product
RayCare 2024A SP4. Oncology Information Systems.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Oncology Information System
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Software Version 8.0.4.60077
  • UDI 0735000201089120241218
  • Expiration Date: 2030-01-24.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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