Elekta XiO Radiation Treatment Planning System Recalled for Incorrect Treatment Delivery
Elekta is recalling 1,440 XiO Radiation Treatment Planning Systems because they may deliver incorrect treatments when using third-party fixed wedges.
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 involves a medical device used for cancer treatment where incorrect delivery poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Elekta, Inc. is recalling 1,440 units of the XiO Radiation Treatment Planning System, version 4.51 and higher. The system is used to create treatment plans for cancer patients prescribed external beam radiation therapy or brachytherapy.
The recall is due to a risk of incorrect treatment delivery when the system is used with third-party fixed wedges. The affected units were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities should contact Elekta, Inc. for further instructions on how to address this issue.
The recalled product
- Product
- XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
- Manufacturer
- Elekta, Inc.
- Affected units
- 1,440
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)
- Version 4.51 and higher
Distribution
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