Elekta XiO RTP System Recalled for Dose Calculation Error
Elekta is recalling 13 XiO RTP Systems because a software error prevents dose recalculation when proton spot beam fractions are changed.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a failure to recalculate radiation dose, which poses a significant risk of harm to patients if not corrected.
Plain-English summary
Elekta, Inc. is recalling 13 units of the XiO RTP System, a medical device used to create treatment plans for cancer patients receiving external beam radiation therapy or brachytherapy. The recall is due to a software defect in versions 4.80 and higher.
The defect occurs when the number of fractions is changed for a proton spot beam. In these instances, the machine units (MU) are recomputed and rounded, but the dose is not recalculated as required, even after the plan is saved and re-opened. This error could result in inaccurate treatment plans.
The affected units were distributed worldwide, including in the United States (Illinois, Indiana, Louisiana, New Jersey, Texas, Washington, and Wisconsin) and in Belgium, Germany, Italy, and the Netherlands. Users should contact Elekta for instructions on how to resolve the software issue.
The recalled product
- Product
- XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional…
- Manufacturer
- Elekta, Inc.
- Affected units
- 13
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)
- Model or Catalog No. MUJ
- Software Version XiO Versions 4.80 and higher
Distribution
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