The Recall Desk
HighFDA (Devices)·Z-1403-2022·Announced 2022-07-27

Radiation treatment planning software fails to propagate treatment course data

RayStation 9B SP1 radiation treatment planning software has an issue where treatment course information may not be propagated to other systems in some workflows. This could potentially affect treatment planning accuracy.

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: This is an FDA Class II medical device recall involving radiation treatment planning software with a potential data propagation defect. While no patient injuries or illnesses have been reported, the product is used in high-risk treatment planning workflows, placing it in the high-risk category per the rubric's criterion for risk-of-harm products without reported injury.

Plain-English summary

RayStation 9B SP1 is radiation treatment planning software manufactured by RaySearch Laboratories AB, used in cancer treatment planning. The software is identified by UDI-DI 0735000201029720200310 and build number 9.2.0.483.

An issue has been identified affecting the propagation of treatment course information from RayStation to connected systems (RayTreat and RayCare). In some workflows, this information may not be propagated properly, potentially resulting in incomplete treatment planning data.

The product has worldwide distribution including the United States (Tennessee), Belgium, and Switzerland. No patient injuries or adverse events have been reported as of the recall announcement.

Healthcare facilities using this software should contact RaySearch Laboratories AB for information on which workflows are affected and for guidance on remediation or software updates.

The recalled product

Product
RayStation 9B SP1. For radiation treatment planning.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Treatment Planning / Software
Hazard
Affected units
1

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 (1)

  • UDI-DI: 0735000201029720200310 Build number 9.2.0.483

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

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Same hazard · data loss

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