Date Initiated by Firm |
July 17, 2020 |
Create Date |
July 27, 2020 |
Recall Status1 |
Terminated 3 on August 30, 2021 |
Recall Number |
Z-2715-2020 |
Recall Event ID |
86076 |
510(K)Number |
K163500
|
Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
|
Product |
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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. |
Code Information |
Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019 |
Recalling Firm/ Manufacturer |
Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium
|
Manufacturer Reason for Recall |
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
|
FDA Determined Cause 2 |
Software design |
Action |
An Urgent Medical Device Correction notification will be communicated to all impacted IBA customers (users of the device), starting July 23, 2020. This letter instructs the customer: If this situation were to occur, it is recommended to complete the aborted treatment in Standalone Mode (please refer to the steps described in annex I and to the part Using adaPTdeliver in Standalone Mode of the Proton Therapy System Clinical Users Guide). IBA will modify the software to remove conditions that make impossible to load the plan to complete the aborted treatment.
The solution will be deployed on your site by June 30, 2022. |
Quantity in Commerce |
2 Units |
Distribution |
US: VA
OUS: Belgium |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = LHN and Original Applicant = Ion Beam Applications S.A.
|