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.
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, 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.
- 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
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