Elekta iGUIDE System Recalled for Potential Position Monitoring Error
Elekta is recalling 374 iGUIDE Systems because they may incorrectly monitor 3D position. The recall covers devices distributed nationwide and 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Elekta, Inc. is recalling 374 iGUIDE Systems with software builds 2.2.0, 2.2.1, and 2.2.2. The recall is due to a potential for the device to incorrectly monitor the 3D position.
The affected devices were distributed nationwide to numerous U.S. states and worldwide to multiple countries. The specific software versions involved are 2.2.0, 2.2.1, and 2.2.2, each with distinct Product Code/GTIN numbers.
Healthcare facilities and users should contact Elekta, Inc. for instructions on how to address the issue. The source text does not specify a particular action for consumers, as this is a medical device used in clinical settings.
The recalled product
- Product
- iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 374
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 (6)
- Version 2.2.0
- Product Code/GTIN Number: 04056719001704
- Version 2.2.1
- Product Code/GTIN Number: 04056719001742
- Version 2.2.2
- Product Code/GTIN Number: 04056719002039
Distribution
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