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U.S. Department of Health and Human Services

Class 2 Device Recall AdaPT insight

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  Class 2 Device Recall AdaPT insight see related information
Date Initiated by Firm September 16, 2016
Create Date June 08, 2018
Recall Status1 Terminated 3 on February 08, 2019
Recall Number Z-2138-2018
Recall Event ID 80221
510(K)Number K132847  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product 12C
Code Information Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126, SBF.101
Recalling Firm/
Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall
IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
FDA Determined
Cause 2
Finished device change control
Action IBA mailed an Urgent Field Safety Notice to affected customers on 09/16/2016 to notify them of the risks associated with the use of this device to prevent serious injury/death. Customers were asked not to make any unauthorized modification to the IBA System or IBA accessories unless approved in writing or in advance by IBA. IBA will be updating their manuals to include these warnings.
Quantity in Commerce S0 Units
Distribution Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
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 and Original Applicant = ION BEAM APPLICATIONS S.A.