Z-0938-2018Class II

Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the...

Name: Z-0938-2018 Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the...
Creator: Ion Beam Applications S.A.
Published: 2017-11-17
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2017-11-17 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and... on 2017-11-17. FDA classified it as Class II and gives the reason as "There is a risk of misalignment of the patient when using treatment plans with multiple isocenters". 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-0938-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2018-03-09
Terminated: 2021-06-14
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235, Proton Therapy System a medical device designed to produce and delivers 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: There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Root cause tag: design
FDA root cause: Device Design
Action: On November 17, 2017 an Urgent Field Safety Notice was issued to customers informing users that when creating or importing a treatment plan with multiple isocenters, the user has to enter Patient Positioning System positions manually.
Quantity in commerce: 37
Distribution: Nationally
Product codes and lots: PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (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.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0938-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0938-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

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)