The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1705-2016·Announced 2016-06-01

Elekta iGUIDE System Software Recall for Radiotherapy Positioning Errors

Elekta, Inc. is recalling 20 iGUIDE Systems due to a software issue that may allow pre-treatment imaging to be performed before the HexaPOD is in the correct position.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically indicates a temporary or non-serious health risk. The source text describes a software workflow issue without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Elekta, Inc. is recalling 20 units of the iGUIDE System, a device used for patient positioning in radiotherapy environments. The recall involves software versions 2.1 and 2.2. The affected units were distributed in Illinois, Louisiana, Austria, Australia, Botswana, Germany, Denmark, France, India, and Japan.

The recall is due to a software defect where the system may allow initial pre-treatment imaging to be performed before the HexaPOD is moved to the DRIVE (*START) position. While the software includes a catch-up workflow to use the initial scan data in this specific scenario, the recall addresses the potential for procedural errors during the positioning process.

Healthcare facilities using these systems should contact Elekta, Inc. for further instructions on how to address the software issue and ensure proper patient positioning protocols are followed.

The recalled product

Product
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiotherapy Equipment
Hazard
Affected units
20

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)

  • Software iGUIDE 2.1 and 2.2

Distribution

Distributed in 2 states:

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