Date Initiated by Firm | April 11, 2016 |
Create Date | June 23, 2018 |
Recall Status1 |
Terminated 3 on March 25, 2020 |
Recall Number | Z-2284-2018 |
Recall Event ID |
80217 |
510(K)Number | K152224 |
Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
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Product | The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)
Proteus 235, Beam Management System (PBS) |
Code Information |
PAT.003 and PAT.006 |
Recalling Firm/ Manufacturer |
Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium
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Manufacturer Reason for Recall | IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue. |
FDA Determined Cause 2 | Software Manufacturing/Software Deployment |
Action | IBA mailed an Urgent Field Safety Notice to affected customers to inform them and prevent risk associated with this issue. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. A software upgrade will be deployed on impacted units to correct this issue. |
Quantity in Commerce | 2 |
Distribution | Units were distributed to Korea and Jacksonville, FL. |
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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