Z-2097-2017Class II

Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a...

Name: Z-2097-2017 Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a...
Creator: Ion Beam Applications S.A.
Published: 2017-04-10
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2017-04-10 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with... on 2017-04-10. FDA classified it as Class II and gives the reason as "A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2097-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Posted: 2017-05-03
Terminated: 2018-02-16
Recalling firm: Ion Beam Applications S.A.
Product: Proton therapy system -Proteus 235 aka Proteus Plus. A medical device 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: A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
Root cause tag: software
FDA root cause: Software design
Action: Target date for software update June 30, 2017. A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual.
Quantity in commerce: 2
Distribution: FL
Product codes and lots: Serial numbers: PAT.003, PAT.006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2097-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2097-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-16

Product code LHN

K152224Class IIProton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. / cleared 2016-08-09

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)