IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
FDA Recall Z-0295-2024 · Posted 2023-11-14
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Recalling FirmIon Beam Applications S.A.
Recall StatusOpen, Classified
Product CodeLHN
Date Initiated2023-09-18
Product Quantity5 (US), 9 (OUS)
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.
Firm Action
An 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: [email protected], Helpdesk: +32 2 507 20 81 (available 24/7).
Root Cause
Device Design
Distribution Pattern
Worldwide - 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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