Elekta XiO RTP System Recalled for Incorrect Effective Depth Calculation
Elekta, Inc. is recalling 1,424 XiO RTP Systems because the software may calculate incorrect Effective Depth values when bolus is present.
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 planning where incorrect calculations could lead to improper treatment, representing a risk of harm where injury has not yet been reported in the source text.
Plain-English summary
Elekta, Inc. is recalling 1,424 units of the XiO RTP System, a medical device used to create treatment plans for cancer patients prescribed external beam radiation therapy or brachytherapy. The recall is due to a software defect where the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect when bolus is present.
The affected units were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international countries. The source text does not specify the exact dates of distribution or the specific lot numbers affected beyond the code 'MUJ'.
Consumers and healthcare facilities should contact Elekta, Inc. for further instructions on how to address this issue. The source text does not provide specific contact details or remediation steps, so users should refer to the official FDA recall notice for guidance.
The recalled product
- Product
- XiO RTP 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
- 1,424
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)
- MUJ
Distribution
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