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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus 235

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 Class 2 Device Recall Proteus 235see related information
Date Initiated by FirmSeptember 16, 2016
Create DateJune 08, 2018
Recall Status1 Terminated 3 on February 08, 2019
Recall NumberZ-2139-2018
Recall Event ID 80221
510(K)NumberK152224 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductProteus ONE and Proteus Plus
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/
Manufacturer		 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
ActionIBA 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.
DistributionUnits were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LHN
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