Elekta Recalls iGUIDE Software 2.2 Due to Incorrect PEC Values
Elekta, Inc. is recalling iGUIDE Software 2.2 because it contains incorrect PEC values. The software is used for patient positioning in radiotherapy environments.
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 situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or deaths, and the hazard is a software error (incorrect PEC values) rather than a direct physical defect causing immediate harm.
Plain-English summary
Elekta, Inc. is recalling iGUIDE Software 2.2, which is used to control accurate patient positioning with the assistance of a 3D Tracking System in a radiotherapy environment. The recall is being conducted because the software contains incorrect PEC values.
The recall covers 110 units of the software, specifically versions iGUIDE 2.2.0 and iGUIDE 2.2.1. These units were distributed worldwide, including in the United States states of AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, and VA, as well as in Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Slovenia, Spain, Sweden, Switzerland, United Kingdom, and Vietnam.
Healthcare facilities using this software should contact Elekta, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
- Manufacturer
- Elekta, Inc.
- Affected units
- 110
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 (3)
- Scope
- iGUIDE 2.2.0
- iGUIDE 2.2.1
Distribution
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