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Class 2 Device Recall Proteus 235 and Proteus ONE proton therapy systems |
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Date Initiated by Firm |
May 18, 2016 |
Create Date |
July 03, 2017 |
Recall Status1 |
Terminated 3 on February 08, 2019 |
Recall Number |
Z-2672-2017 |
Recall Event ID |
77620 |
510(K)Number |
K132919
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Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
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Product |
Proteus 235 and Proteus ONE proton therapy systems |
Code Information |
Code/Serial Numbers: 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 and SAT.126 |
Recalling Firm/ Manufacturer |
Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium
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Manufacturer Reason for Recall |
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
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FDA Determined Cause 2 |
Employee error |
Action |
An Urgent Field Safety Notice MID-54097 was mailed to affected customers to inform that IBA plans to deploy a new software by March 2017 to correct the issue. Customers were reminded to follow standard protocol until the software updates are deployed. |
Quantity in Commerce |
18 worldwide and 10, in the U.S. |
Distribution |
Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden |
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.
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510(K) Database |
510(K)s with Product Code = LHN and Original Applicant = ION BEAM APPLICATIONS S.A.
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