Date Initiated by Firm |
November 07, 2014 |
Date Posted |
December 19, 2014 |
Recall Status1 |
Terminated 3 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 |
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
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FDA Determined Cause 2 |
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
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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 and Original Applicant = ION BEAM APPLICATIONS S.A.
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