PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 31, 2014 Initiated: November 7, 2014 #Z-0836-2015

Product Description

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.

Reason for Recall

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

Details

Units Affected
1
Distribution
US Distribution in PA only.
Location
Louvain La Neuve

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Ion Beam Applications S.A.. Units affected: 1.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2014. Severity: Moderate. Recall number: Z-0836-2015.

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