FDA Device recall Z-0380-2018

RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy

• FDA Device
• Class II
• terminated
• Published 2018-01-24

On 2018-01-24 the FDA classified a Class II recall of RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy by Raysearch Laboratories Ab, citing for the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed….

Read the official FDA Device notice

Product

RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

Reason

For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0380-2018%22

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