Z-2155-2021Class II

Proteus 235-Proton Therapy System

Name: Z-2155-2021 Proteus 235-Proton Therapy System
Creator: Ion Beam Applications S.A.
Published: 2021-05-26
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2021-05-26 / Open, Classified / root cause: labeling and UDI

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235-Proton Therapy System on 2021-05-26. FDA classified it as Class II and gives the reason as "if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2155-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-26
Posted: 2021-07-28
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235-Proton Therapy System
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: IBA issued Urgent Medical Device Correction notification starting on May 27, 2021. Letter states reason for recall, health risk and action to take: IBA would like to remind Proteus235 users of the following warning present in the Clinical User Guide: As a Radiation Therapy Technologist (RTT), check before allowing the irradiation that the position of the selector switch of the external beam triggering interface is consistent with the prescription data in the patient file. There is a risk of mistreatment as the system does not automatically detect the gating prescription thereby always generating a continuous irradiation. Labelling change and training IBA will: - update the user manuals to recommend the customers to define a procedure for patients with gating prescribed in order to ensure that the system will be set correctly, - provide user training sessions about the preparation of a treatment with UBTI synchronization. The actions will be performed for your site by December 31, 2021. Your IBA representative is able to provide you with additional information and/or guidelines if necessary.
Quantity in commerce: 5 US; 8 OUS
Distribution: FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
Product codes and lots: Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2155-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2155-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-28

Product code LHN

K101508Class IIModification to Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. / cleared 2010-08-06

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)