Recall Z-0836-2015— Ion Beam Applications S.A.

Name: FDA recall Z-0836-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-07

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2014-11-07, terminated 2015-06-29. It names one FDA 510(k) clearance: K132847. 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.. Reason: 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.

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2014-11-07
Terminated: 2015-06-29
Firm location: Louvain La Neuve, Belgium

510(k) clearances named in this recall

1 on FDA's record

K132847 — I2CIon Beam Applications S.A.·cleared 2013-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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