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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus Plus, Proteus ONE

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 Class 2 Device Recall Proteus Plus, Proteus ONEsee related information
Date Initiated by FirmAugust 07, 2016
Create DateJune 12, 2018
Recall Status1 Terminated 3 on March 25, 2020
Recall NumberZ-2173-2018
Recall Event ID 80222
510(K)NumberK132919 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductProteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
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.
FEI Number 3000256071
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
For Additional Information Contact
215-972-7985
Manufacturer Reason
for Recall		IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
FDA Determined
Cause 2		Employee error
ActionIBA mailed out a Field Safety Notice on August 2, 2016, to affected customers where this maintenance is not performed by IBA technicians to inform them of the issue. For further questions please call (215) 972-7985.
Quantity in Commerce19 units
DistributionUnits were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
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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