The Recall Desk
HighFDA (Devices)·Z-1482-2024·Announced 2024-04-17

RayStation Software Use Error Could Cause Incorrect Radiation Dose Calculations

RayStation radiation therapy planning software versions 8B through 2024A contain a use error that can incorrectly select silicon material for silicone gel polymer implant dose calculations, potentially resulting in incorrect radiation doses.

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: FDA Class II medical device recall involving a use error in radiation therapy planning software that could lead to incorrect radiation dose calculations. No illnesses or injuries have been reported, making this a risk-of-harm scenario where injury has not yet been documented.

Plain-English summary

RayStation is radiation therapy planning software used by medical facilities to calculate radiation doses for cancer treatment. Affected versions (8B through 2024A) contain a use error where material selection can be overridden to incorrectly choose Silicon (Si) instead of the correct silicone gel polymer material for implants, which could result in inaccurate radiation dose calculations.

This use error has been reported to occur with RayStation and RayPlan modules. The 154 affected units have been distributed worldwide, including throughout the United States and in over 40 countries including Canada, Japan, Germany, United Kingdom, Australia, and others.

Healthcare providers using affected RayStation software versions should verify that material selections for silicone gel polymer implants are correct before finalizing radiation treatment plans. Contact RAYSEARCH LABORATORIES AB for software updates that correct this use error.

The recalled product

Product
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning Software
Hazard
  • use-error
  • dose-calculation-error
  • radiation-safety

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 (20)

  • Version Number (Build Number/UDI): 8B (8.1.0.47/07350002010129)
  • 8B SP1 (8.1.1.8/07350002010204)
  • 8B SP2 (8.1.2.5/07350002010235)
  • 9A (9.0.0.113/07350002010174)
  • 9A SP1 (9.0.1.142/07350002010488)
  • 9B (9.1.0.933/07350002010266)
  • 9B SP1 (9.2.0.483/07350002010297)
  • 10A (10.0.0.1154/07350002010303)
  • 10A SP1 (10.0.1.52/07350002010365)
  • 10A SP2 (10.0.2.10/07350002010655)
  • 10B (10.1.0.613/07350002010310)
  • 10B SP1 (10.1.1.54/07350002010471)
  • 11A (11.0.0.951/07350002010389)
  • 11A SP1 (11.0.1.29/07350002010433)
  • 11A SP2 (11.0.3.116/07350002010440)
  • 11A SP3 (11.0.4.15/07350002010631)
  • 11B (12.0.0.932/07350002010426)
  • 11B SP1 (12.1.0.1221/07350002010495)
  • 11B SPC1 (12.1.1.41/07350002010587)
  • 11B SP2 (12.0.3.68/07350002010501)

Distribution

Distributed nationwide across the United States.

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