Ion Beam Applications S.A. adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C 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 radiation therapy device. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C 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 radiation therapy device.
Brand
Ion Beam Applications S.A.
Lot Codes / Batch Numbers
PAT.109 (US), Treatment room 4
Products Sold
PAT.109 (US), Treatment room 4
Ion Beam Applications S.A. is recalling adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or due to Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geom. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams colinearity, du
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, PA
Page updated: Jan 13, 2026