The Recall Desk
HighFDA (Devices)·Z-2206-2016·Announced 2016-07-27

RayStation Radiation Therapy Software Recalled for Incorrect Biological Goal Evaluation

RaySearch Laboratories is recalling RayStation radiation therapy software versions 3.0 through 5 due to incorrect biological clinical goal values for adapted plans.

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 with a defect that could lead to incorrect treatment planning, but the source explicitly states that no patient mistreatment or incidents have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation 3.0, 3.5, 4.0, 4.5, 4.7, and 5 Radiation Therapy Treatment Planning Systems. The recall affects 170 units distributed in California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas, and Washington. The software is designed for treatment planning and analysis of radiation therapy, providing treatment unit setup parameters and dose distribution estimates.

The recall is due to an issue with the evaluation of biological clinical goals. Specifically, biological clinical goals for an adapted plan based on a planning CT different from the original planning CT will display incorrect values. To the best of the firm's knowledge, this issue has not caused any patient mistreatment or other incidents.

Users must be aware of this information to avoid incorrect plan evaluation during treatment planning. The recall covers specific software build numbers ranging from 3.0.0.251 to 5.0.2.35.

The recalled product

Product
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose dist
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
170

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 (17)

  • Software build numbers: 3.0.0.251
  • 3.5.0.16
  • 3.5.1.6
  • 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.42
  • 4.5.0.19
  • 4.5.1.14
  • 4.5.2.7
  • 4.7.0.15
  • 4.7.1.10
  • 4.7.2.5
  • 4.7.4.4
  • 4.7.5.4
  • 5.0.0.37
  • 5.0.1.11 and 5.0.2.35

Distribution

Distributed in 11 states:

Related recalls

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