Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Recall Z-2470-2018 · Posted None
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Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2018-06-27
Date Terminated2020-05-20
Product Quantity14
Reason for Recall
Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.
Firm Action
Recall was initiated on 6/27/18. Firm plans to provide the Urgent Medical Device Correction notifications to IBA site managers present on customer sites. The site managers will deliver the notification to customers by hand or email.
The recall letter alerts users to the potential issue and instructs users to verify that apertures and accessories are fully inserted with both sides in the guide. The firm plans to deploy a solution on or before May 31, 2019, that will prevent occurrences of the issue.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
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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