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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusPLUS and ProteusONE

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 Class 2 Device Recall ProteusPLUS and ProteusONEsee related information
Date Initiated by FirmSeptember 18, 2023
Date PostedNovember 14, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0295-2024
Recall Event ID 93293
510(K)NumberK163500 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductIBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Code Information UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.
FEI Number 3000256071
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin Du Cyclotron 3
Ottignies-Louvain-La-Neuve Belgium
For Additional Information ContactSonia Pinel
32-25072081
Manufacturer Reason
for Recall		The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
FDA Determined
Cause 2		Device Design
ActionAn Urgent Medical Device Correction issued on October 4, 2023 by email or in-person visit. Waiting for the solution to be deployed, IBA requires the user to only request jog translation motions to recover from a collision situation. IBA also recommends the user to post the notice near the device to remind them of this requirement until the software correction can be deployed. IBA provide an updated Urgent Medical Device Correction notification by November 30, 2023 with a target date for deployment of the software solution to your site. Customers are to complete and return the acknowledgement form to IBA. IBA Contact: Sonia Pinel Head of Post Market Vigilance, Email: Vigilance@iba-group.com, Helpdesk: +32 2 507 20 81 (available 24/7).
Quantity in Commerce5 (US), 9 (OUS)
DistributionWorldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LHN
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