Use cautionMedical device recall · FDA · Published June 27, 2018
Ion Beam Applications Proteus 235 Recall: Risk of Patient Injury from Improper Alignment
Ion Beam Applications recalls Proteus 235 proton therapy devices due to risk of patient or user injury from improper nozzle alignment during treatment. Affected units may cause crushing or mistreatment if apertures aren't correctly positioned.
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.
Ion Beam Applications is recalling its Proteus 235 proton therapy devices because improper alignment of the nozzle components can cause injury to patients or users. This risk occurs when the apertures or accessories aren't correctly positioned in the snout 300x400 or snout XL models. Read more at govinfonow.com/recall/70735-ion-beam-applications-proteus-235-recall-risk-of-patient-injury.
“Ion Beam Applications Proteus 235 Recall: Risk of Patient Injury from Improper Alignment.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70735-ion-beam-applications-proteus-235-recall-risk-of-patient-injury. Based on FDA recall #Z-2470-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2470-2018%22&limit=1).
Ion Beam Applications S.A. recalled Proteus 235 and Universal Nozzle units with snout 300x400 or XL on June 27, 2018, according to the FDA. The hazard involves potential crushing of patients or users if apertures are mispositioned during gantry rotation. The agency announced this Class II voluntary recall.
How to tell if you have it
Brand: Ion Beam Applications
Products: Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL
Units affected: 14
Serial numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.113, PAT.114, PAT.115, PAT.116, PAT.120, PAT.126, and PAT.132
Distribution: US Nationwide in FL, VA, PA, OK, NJ, WA, and TX
The hazard
The FDA stated that gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This condition creates a risk of crushing for the patient and/or user, as well as a risk of mistreatment for the patient.
Context
GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since October 17, 2017. Other recent recalls of similar products include IBA Proton Therapy System PROTEUS 235 Recall: Risk of Mistreatment Without Safety Check (February 3, 2026), Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Collision Detection Issues (July 10, 2024), and Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation (July 8, 2024). Other recent recalls of similar products include Hitachi Proton Beam Therapy System Recall: Positioning Software Anomaly Risk (February 6, 2026) and Zeiss Intrabeam Spherical Applicator 1.5 cm Recall: Manufacturing Defect (June 1, 2026).
How to tell if you have this one
Check for the Proteus 235 model with either the Universal Nozzle and snout 300x400 or PBS dedicated nozzle with snout XL. These devices were sold with the specified patents listed in the recall notice.
Brand
Ion Beam Applications
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Alignment
Ensure apertures and accessories are correctly positioned in the snout 300x400 or snout XL before use.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2470-2018 (June 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2470-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.