adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation the

FDA device recall Z-0836-2015 · posted 2014-12-19 · Terminated

Recall details

Recalling firm

Ion Beam Applications S.A.

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

Action taken

The firm, IBA, sent a " User Notice" dated November 7, 2014, to the sole affected site-UPHS Customer. The notice describes the product, problem and actions to be taken. The customer was instructed that the KV/kV source acquisition mode has been disabled and shall not be used for patient alignment until system is officially confirmed to be back within tolerances. IBA will change the kV/kV Single Source acquisition workflow configuration file to be linked to the correct geometrical calibration file and will update the kV/kV Single Source calibration file that includes the colinearity parameters, with the correct values. If you need assistance, contact the IBA Site Staff or the Operations manager at +32 10 475 997 or email: Sophie.dessart@iba-group.com.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

LHN

Quantity affected

1

Distribution

US Distribution in PA only.

Date initiated

2014-11-07

Date posted

2014-12-19

Date terminated

2015-06-29

Location

Louvain La Neuve, Belgium

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