Date Initiated by Firm | December 13, 2016 |
Create Date | July 04, 2017 |
Recall Status1 |
Terminated 3 on April 12, 2019 |
Recall Number | Z-2684-2017 |
Recall Event ID |
77621 |
510(K)Number | K152224 |
Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
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Product | Proteus 235, Proton Therapy System
Product Usage:
The Proton Therapy System - Proteus 235 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 |
Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003 |
Recalling Firm/ Manufacturer |
Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium
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Manufacturer Reason for Recall | Software issue |
FDA Determined Cause 2 | Software design |
Action | An Urgent Field Safety Notice was mailed to affected customers to inform them of the issue. The notice indicated possible software failure, the associated risks and actions users should implement to correct the issue. IBA plans to follow-up with a software update which will be deployed on impacted sites to correct this issue. |
Quantity in Commerce | 6 worldwide and 5 in the U.S. |
Distribution | Distributed to FL, VA, IL, NJ, WA and South Korea |
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
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