Ion Beam Applications Recalls 12C AdaPTinsight Radiation Therapy Software
Ion Beam Applications is recalling 12C units due to an issue with the AdaPTinsight software used for patient localization in radiation therapy.
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 radiation therapy where a software issue could impact patient localization and treatment accuracy. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where specific injury or illness has not yet been reported in the source text.
Plain-English summary
Ion Beam Applications S.A. is recalling five units of the 12C (AdaPTinsight) system. The affected component is the AdaPTinsight software, which is used with charged particle or photon radiation therapy systems to localize patient position and provide correction feedback to the therapy equipment.
The recall is being initiated to address an issue identified with the AdaPTinsight software and to reduce the risk related to this problem. The affected units are identified by the codes SAT.123, SAT.126, PAT.115, SAT.122, and SBF.101.
These units were distributed worldwide, including in the United States (Louisiana and Texas), Italy, Sweden, and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.
The recalled product
- Product
- 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the…
- Manufacturer
- Ion Beam Applications S.A.
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 (4)
- Affected units: SAT.123
- SAT.126
- PAT.115
- SAT.122 and SBF.101
Distribution
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