Z-2434-2021Class II

Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized...

Name: Z-2434-2021 Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized...
Creator: Ion Beam Applications S.A.
Published: 2021-06-14
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2021-06-14 / Open, Classified / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by... on 2021-06-14. FDA classified it as Class II and gives the reason as "Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2434-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-14
Posted: 2021-09-08
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Root cause tag: design
FDA root cause: Device Design
Action: IBA issued an Urgent Medical Device Correction notification users of the device, starting June 14, 2021. Letter states reason for recall, health risk and action to take: IBA would like to remind Proteus235 users to verify with X-ray images or other means, after the display of the popup message, that the patient positions (represented by the couch position, mainly the 3 translations and 3 rotations parameters) recorded in the OIS are correct Labelling change IBA will update the user manuals to: - Describe under which conditions the popup message appears and the subsequent risks, especially that the equipment positions may not be up to date in the OIS, - Remind the user to verify with X-ray images or other means, after the display of the popup message, that the patient positions (represented by the couch position, mainly the 3 translations and 3 rotations parameters) recorded in the OIS are correct, - Recommend the user to verify the OIS user manuals for measures preventing saving outdated patient positions in case of disconnection and to apply these measures before saving the positions in the OIS. The action will be completed for your site by May 31, 2022. By signing below, the customer representative confirms that this notice has been read, understood and communicated to the appropriate employees within the organization. Please transfer this notice to other organizations on which this action has an impact. Your IBA representative is able to provide you with additional information and/or guidelines if necessary. Please return the copy of the notice signed to IBA within 10 working days .
Quantity in commerce: 27 worldwide, 11 in U.S.
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.
Product codes and lots: PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (EU).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2434-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2434-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-15	2021-09-10

Product code LHN

K061913Class IIIba Proton Therapy System - Proteus 235Ion Beam Applications S.A. / cleared 2006-07-28

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)