The Recall Desk
HighFDA (Devices)·Z-1930-2019·Announced 2019-07-10

RaySearch Recalls Radiation Therapy Planning Software Due to Dose Calculation Errors

RaySearch Laboratories AB is recalling RayStation and RayPlan software versions because electron Monte Carlo dose calculations may be incorrect when using a very large number of histories.

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: The recall involves a medical device software defect that could lead to incorrect radiation dose calculations, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

RaySearch Laboratories AB is recalling specific versions of RayStation and RayPlan software, which are designed for treatment planning and analysis of radiation therapy. The recall involves 744 units distributed nationwide in the United States.

The recall was initiated because the software may produce incorrect dose calculations when calculating electron Monte Carlo dose with a very large number of histories. This defect could affect the accuracy of radiation therapy treatment plans.

Healthcare providers and users of the affected software versions should contact RaySearch Laboratories AB for further instructions on how to address the issue. The affected software versions include specific releases of RayStation 3.5 through 6.2 and RayPlan 1 and 2.

The recalled product

Product
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
744

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)

  • Software versions: 3.5.0.16
  • 3.5.1.6
  • 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.4
  • 4.5.0.19
  • 4.5.1.14
  • 4.5.2.7
  • 4.7.0.15
  • 4.7.1.10
  • 4.7.2.5
  • 4.7.3.13
  • 4.7.4.4
  • 4.7.5.4
  • 4.9.0.42
  • 5.0.0.37
  • 5.0.1.11
  • 5.0.2.35
  • 5.0.3.17

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

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