Z-0747-2022Class II

ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with...

Name: Z-0747-2022 ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with...
Creator: Ion Beam Applications S.A.
Published: 2022-02-15
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2022-02-15 / Open, Classified / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible... on 2022-02-15. FDA classified it as Class II and gives the reason as "When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually...". 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-0747-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-15
Posted: 2022-03-10
Recalling firm: Ion Beam Applications S.A.
Product: ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
Root cause tag: design
FDA root cause: Device Design
Action: IBA issued Urgent Medical Device Correction notification on February 15, 2022 directly to customer either by hand or by email. Letter states reason for recall, health risk and action to take: For Proton Therapy sites where the system is operated by the customer: - Warn operators to not manually change the beam range (action called manual set range ) while a patient is on the Patient Positioning System. - IBA will provide a training to all operators about the correct use of the action called manual set range and the risk associated to its use while a patient is on the Patient Positioning System. This training will be provided on your site by August 31, 2022. Contact: [email protected]. Help Desk: +32 2 507 20 81 (available 24/7)
Quantity in commerce: 15 units US; 22 units OUS
Distribution: IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,
Product codes and lots: PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109 (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK), SBF.117 (EU), SBF.128 (US). UDI: (01)05404013801138

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0747-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0747-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-10

Product code LHN

K163500Class IIIBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A. / cleared 2017-08-17

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)