The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1281-2023·Announced 2023-03-29

Raystation Treatment Planning System Collimator Angle Export Defect

Raystation radiation therapy planning software may not correctly export collimator angle settings when using the DICOM export function. In exported files, the collimator angle may be replaced with zero regardless of the user's selection.

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: This is an FDA Class II recall with no reported hospitalizations or patient injuries. The defect represents a risk-of-harm product (radiation therapy planning system) where incorrect treatment parameters could potentially be applied, matching the rubric criterion for High severity.

Plain-English summary

Raystation is a treatment planning system used in radiation therapy. The recall affects approximately 10,770 units distributed nationwide in the United States. Affected versions include model numbers 9.0.0 through 13.1.0 with corresponding software versions 9A through 12A and service packs.

A defect exists in the Virtual Simulation module's DICOM export function. When users set a non-zero collimator angle in the system, the angle displays correctly in the user interface. However, when the treatment plan is exported to DICOM format using the VSIM Export button, the collimator angle is not correctly transferred. Instead, the Beam Limiting Device Angle (DICOM attribute 300A,0120) is set to zero in the exported file, regardless of the collimator angle selected by the user.

This defect has the potential to affect patient safety because exported treatment plans may contain incorrect collimator angle settings that do not match what the radiation therapist selected. Affected users include radiation therapy facilities and clinicians using the affected Raystation versions.

The recalled product

Product
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B…
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning Software
Hazard
Affected units
10,770

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 (1)

  • UDI-DI: 0735000201067920221007

Distribution

Distributed nationwide across the United States.

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