Class 2 Device Recall adaPT insight (12C), v1.3.2

• Date Initiated by Firm: November 07, 2014
• Date Posted: December 19, 2014
• Recall Status: Terminated on June 29, 2015
• Recall Number: Z-0836-2015
• Recall Event ID: 69781
• 510(K)Number: K132847
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• 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.
• Code Information: PAT.109 (US), Treatment room 4
• FEI Number: 3000256071
• Recalling Firm/ Manufacturer: Ion Beam Applications S.A.; Chemin du Cyclotron, 3; Louvain La Neuve Belgium
• Manufacturer 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
• FDA Determined Cause: Software design (manufacturing process)
• Action: 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.
• Quantity in Commerce: 1
• Distribution: US Distribution in PA only.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = LHN