The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0380-2018·Announced 2018-01-24

RayStation 6 Proton QA Module Recall for Potential Dosage Errors

RaySearch Laboratories is recalling RayStation 6 software due to a defect in the proton QA module that may result in incorrect patient dosage calculations.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of incorrect dosage to patients, which aligns with the rubric for Severe severity (FDA Class II with potential for significant injury).

Plain-English summary

RaySearch Laboratories AB is recalling 117 units of RayStation 6 software, specifically versions 6.0.0.24, 6.1.0.26, 6.1.1.2, and 6.2.0.7. The recall involves the proton QA preparation module, including Service Packs 1 and 2. The software is used for treatment planning and analysis of radiation therapy.

The recall was initiated because if the snout position or gap is modified in the QA module, the dose may be computed for a different setup than what is used for QA measurements. This defect could result in an incorrect dosage being provided to a patient. The affected units were distributed nationwide in the United States, including in Florida, Washington, Arizona, Tennessee, Maryland, Texas, Michigan, and Washington D.C.

The U.S. Food and Drug Administration has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the software is intended for use by medical professionals after review and approval.

The recalled product

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…
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
117

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)

  • 6.0.0.24
  • 6.1.0.26
  • 6.1.1.2 or 6.2.0.7

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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