The Recall Desk
SevereFDA (Devices)·Z-2497-2018·Announced 2018-07-25

RayStation Software Recalled for Potential Radiation Overdose Risk

RaySearch Laboratories is recalling RayStation treatment planning software versions 4.5 through 8A because a calculation error could lead to significant radiation overdosage during therapy.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device defect that could lead to significant radiation overdosage, which constitutes a risk of serious injury, aligning with the 'Severe' criteria for significant injury reports or high-risk medical device defects.

Plain-English summary

RaySearch Laboratories AB is recalling 746 units of RayStation stand-alone software treatment planning systems, including versions 4.5, 4.7, 4.9, 5, 6, 7, and 8A. The software is used by clinically qualified radiation therapy staff to plan and analyze radiation treatments. The affected units were distributed nationwide to accounts in 33 states and the District of Columbia.

The recall is due to a defect in how the software calculates DMLC fields when the collimator is rotated and the beam model has a highly asymmetric primary source. This calculation error could lead to potentially significant overdosage at delivery. The source text notes that users must be aware of the issue to avoid incorrect dose calculations during treatment planning.

No specific dates, lot numbers, or reported injuries are provided in the source text. Users of the affected software versions should contact RaySearch Laboratories for further instructions on how to address the calculation issue.

The recalled product

Product
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
746

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 (19)

  • Software Versions 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
  • 5.0.2.3
  • 6.0.0.24
  • 6.1.0.26
  • 6.1.1.2
  • 6.2.0.7
  • 7.0.0.19
  • 8.0.0.61

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

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