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.
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, 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.
- 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
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