The Recall Desk
ModerateFDA (Devices)·Z-1807-2014·Announced 2014-06-25

Elekta iGUIDE System Recalled Due to Software Logoff Bug

Elekta, Inc. is recalling 224 iGUIDE Systems because a software bug prevents the system from logging off. The recall covers units distributed worldwide.

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, and the source text does not report any injuries, illnesses, or deaths. The defect is a software bug preventing logoff, which is a functional issue without explicit evidence of significant harm, fitting the Moderate category for low-risk or voluntary precautionary recalls.

Plain-English summary

Elekta, Inc. is recalling 224 units of the iGUIDE System, a medical device intended for the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment. The recall is due to a bug in the software that prevents the iGUIDE software from logging off.

The affected software versions are 2.0.0, 2.0.1, and 2.0.2. The devices were distributed worldwide, including in the United States and numerous international locations. The source text does not specify any reported injuries, illnesses, or deaths associated with this defect.

Consumers and healthcare facilities should contact Elekta, Inc. for instructions on how to resolve the software issue.

The recalled product

Product
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiotherapy Equipment
Hazard
Affected units
224

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 (2)

  • Software Versions 2.0.0
  • 2.0.1 and 2.0.2

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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