The Recall Desk
HighFDA (Devices)·Z-1598-2020·Announced 2020-04-01

RayStation software recall due to virtual wedge field limitations

RaySearch Laboratories is recalling RayStation software because virtual wedge fields may not cover the entire field, resulting in a high dose plateau.

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 used for radiation therapy where a software defect could result in unintended high dose delivery (high dose plateau), representing a risk of harm where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation standalone software treatment planning systems, including model numbers 4.0 through 9.1. The recall involves 1,389 licenses distributed nationwide in the United States.

The recall is issued because, due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields is more restricted in the wedged direction than without a wedge. Delivering a larger field opening with a virtual wedge does not result in a wedged field shape over the entire field. Instead, a high dose plateau region occurs at the toe side of the field beyond the recommended field size.

Authorized intended users who use RayStation for radiation therapy and medical oncology should contact RaySearch Laboratories AB for further instructions on how to address this issue.

The recalled product

Product
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. Aft
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
1,389

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)

  • Systems with software versions: 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
  • 4.7.6.7
  • 4.9.0.42
  • 5.0.0.37
  • 5.0.1.11
  • 5.0.2.35
  • 5.0.3.17
  • 6.0.0.24

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Related recalls

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