The Recall Desk
HighFDA (Devices)·Z-0848-2022·Announced 2022-04-06

Radiation therapy planning software subject to jaw positioning errors during optimization

RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.

What this means for you

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 medical device with a documented software defect. No illnesses or injuries have been reported. The defect is in a critical medical device (radiation therapy planning software) where incorrect operation could cause patient harm, but falls under the category of 'risk-of-harm products where injury has not yet been reported,' warranting a High (3) severity.

Plain-English summary

RayStation is radiation therapy planning software used to create treatment plans for cancer patients. Affected versions are 6 through 11A.

In the dynamic jaw mode, if a user adjusts the radiation dose, changes where the radiation will be focused (target area), and then continues the optimization process, the software may unexpectedly change the position of the jaws that shape the radiation beam. This can result in treatments being planned incorrectly.

The recall affects 51 licenses in the United States, distributed across 15 states: Alabama, California, Florida, Georgia, Iowa, Illinois, Missouri, Mississippi, North Carolina, Oklahoma, Oregon, South Carolina, Tennessee, Washington, and Wisconsin.

Doctors and medical physicists using RayStation should carefully review their treatment plans after any optimization that follows changes to the radiation dose or target area. This is especially important to catch any unexpected jaw movements before radiation is delivered to patients.

The recalled product

Product
TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.2
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning
Hazard
  • treatment-planning-error
  • software-defect

Distribution

Distributed nationwide across the United States.

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