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Radiation Therapy Treatment Planning System recalls

The FDA has posted 35 enforcement recalls of radiation therapy treatment planning system devices since 2025, none of them Class I (most serious). Most recent report: Jul 8, 2026.

Class II: 35

Who is recalling these devices

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Class IIOngoingZ-2646-2026

RAYSEARCH LABORATORIES AB recalls RayCare 2024A SP1. Oncology Information Systems.

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.

  • Radiation Therapy Treatment Planning System
  • Under Investigation by firm
RAYSEARCH LABORATORIES…Jul 8, 2026
Class IIOngoingZ-2647-2026

RAYSEARCH LABORATORIES AB recalls RayCare 2024A SP4. Oncology Information Systems.

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.

  • Radiation Therapy Treatment Planning System
  • Under Investigation by firm
RAYSEARCH LABORATORIES…Jul 8, 2026

Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“System, Planning, Radiation Therapy Treatment”). Informational only — verify against the FDA before acting.