Z-2470-2018Class II

Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL

Name: Z-2470-2018 Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL
Creator: Ion Beam Applications S.A.
Published: 2018-06-27
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2018-06-27 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of 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... on 2018-06-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2470-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-27
Posted: 2018-07-17
Terminated: 2020-05-20
Recalling firm: Ion Beam Applications S.A.
Product: 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.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 14
Distribution: US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2470-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2470-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17

Product code LHN

K060695Class IIIba Proton Therapy System - Proteus 235Ion Beam Applications S.A. / cleared 2006-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)