The Recall Desk
ModerateFDA (Devices)·Z-1712-2016·Announced 2016-06-01

RayStation Therapy Treatment Planning Software Recalled for Synchronization Bug

RaySearch Laboratories is recalling RayStation Therapy Treatment Planning System software due to a bug that can cause views to become unsynchronized with stored data.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text explicitly states that the bug does not affect dose computations, indicating a theoretical risk of data synchronization issues rather than a direct risk of serious injury or death, which aligns with a Moderate severity rating for a software defect without reported harm.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System Stand-alone Software versions 3.0, 3.5, 4.0, 4.5, and 4.7. The recall involves 1,264 total units, with 552 units distributed domestically and 711 units distributed internationally.

The recall is due to a software issue with editing tools that use the left mouse button held down for drawing and interacting with patient views and beams eye views. The views can become unsynchronized with the stored data if a user simultaneously right-clicks, presses Ctrl-S, or presses Ctrl-Z while holding the left mouse button. The source text states that this bug does not affect dose computations, which are based on the stored system state.

The affected software was distributed in the United States (AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA, and Washington D.C.) and internationally in Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. Users should contact RaySearch Laboratories AB for further instructions regarding the software update or resolution.

The recalled product

Product
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard

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 (14)

  • 3.0.0.251
  • 3.5.0.16
  • 3.5.1.6
  • 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.4
  • 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 or 4.7.4.4

Distribution

Distributed in 24 states:

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