The Recall Desk
HighFDA (Devices)·Z-1299-2022·Announced 2022-07-06

Radiation therapy software shows misleading dose display in RayStation 11B

RayStation 11B radiation therapy planning software has two display issues affecting Linear Energy Transfer values. These errors could lead to incorrect dose calculations if not identified during clinical review.

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 a Class II medical device recall involving software display errors that could affect dose calculations in radiation therapy planning. While the potential harm is serious, no illnesses or injuries have been reported, and the hazard is described as possible rather than confirmed. Per the rubric, risk-of-harm products without reported injuries score at the High level.

Plain-English summary

RayStation 11B, a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB, is being recalled due to two software display issues related to Linear Energy Transfer (LET) display.

The first issue occurs when using a dose threshold for evaluation—the LET display may show misleading values that do not accurately represent the radiation dose distribution. The second issue causes beam-specific LET distribution displays to sometimes become out of sync with the currently selected beam, resulting in a mismatch between what the user selected and what is displayed.

Affected systems are distributed in New Jersey and Texas. Radiation therapy clinics using RayStation 11B with software versions 12.0.0.932, 12.1.0.1221, or 12.0.3.68 should verify that their quality assurance processes identify these display discrepancies before treatment planning. Users should contact RaySearch Laboratories AB for software updates or corrections.

The recalled product

Product
RayStation 11B
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning Software
Hazard
Affected units
26

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)

  • UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932
  • 12.1.0.1221
  • 12.0.3.68

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

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