IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, P

FDA device recall Z-3089-2024 · posted 2024-09-10 · Open, Classified

Recall details

Recalling firm

Ion Beam Applications S.A.

Reason for recall

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

Action taken

IBA issued AMENDED Urgent Medical Device Correction letter (IBA REFERENCE NCIPT-27531) on 7/10/24 provided by IBA directly to the customer either by hand or by email. Letter states reason for recall, health risk and action to take: Regarding Proteus 235 with a PTS-8, PTS-10, PTS-11 or PTS-12 versions: actions: Regarding the malfunction of Safety Parameters Verification Mechanism within BAPP . IBA carried out an analysis to determine if the impacted sites have some safety parameters checked by the BAPP in their clinical site configuration with values leading to violations. The result of this analysis showed that there are no sites with safety parameters checked by the BAPP out of tolerance. Regarding the possibility to disable a Safety Parameters Verification Mechanism (concerns PTS-8, PTS-10, PTS-11 or PTS-12 versions): IBA will carry out an analysis to determine if the impacted sites have specific configuration parameters that allow to deactivate the Safety Parameters Verification Mechanisms in the clinical configuration and if the case, remove them from the clinical site configuration. The result of the analysis will be provided to you on July 31, 2024, at the latest. Final solutions: Regarding the malfunction of Safety Parameters Verification Mechanism within BAPP (only concerns PTS-10, PTS-11 or PTS-12 versions): IBA will ensure that the system cannot be used in clinical with safety parameters checked by the BAPP out of tolerances. Regarding the possibility to disable a Safety Parameters Verification Mechanism (concerns PTS-8, PTS-10, PTS-11 or PTS-12 versions): IBA will ensure that the system displays a Red Banner informing the customer that the system must not be used for clinical activities when safety parameter Verification Mechanisms are deactivated to prevent the users from treating patients. The intermediate action will be implemented for your site by August 31, 2024, at the latest. The final solution will be implemented for your site by June 2026. Fi

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LHN

Quantity affected

35 units

Distribution

Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.

Date initiated

2024-07-08

Date posted

2024-09-10

Location

Ottignies-Louvain-La-Neuve, Belgium

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