Ion Beam Applications Recalls adaPT insight Software Due to Calibration Error
Ion Beam Applications S.A. is recalling one unit of adaPT insight software in Pennsylvania due to a calibration file error and a gantry collision incident.
What this means for you
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 localization where a calibration error could lead to misalignment, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Ion Beam Applications S.A. is recalling one unit of the adaPT insight (12C) v1.3.2 software, identified by code PAT.109 (US) for Treatment room 4. The software is used with charged particle or photon radiation therapy systems to localize patient position and provide correction feedback to the therapy device. The recall is limited to distribution in Pennsylvania.
The recall was initiated due to two identified issues. First, the kV/kV Single Source acquisition workflow in the software release was linked to an incorrect geometrical calibration file, resulting in an alignment offset for that specific acquisition mode. Second, a gantry collision incident required the IBA service team to verify the gantry alignment and the colinearity of protons and I x-ray beams.
The recalled product
- 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.
- Manufacturer
- Ion Beam Applications S.A.
- Affected units
- 1
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)
- PAT.109 (US)
- Treatment room 4
Distribution
Distributed in 1 state:
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