Z-1830-2017Class II

Proteus 235, Proton Therapy System

Name: Z-1830-2017 Proteus 235, Proton Therapy System
Creator: Ion Beam Applications S.A.
Published: 2017-03-21
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2017-03-21 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235, Proton Therapy System on 2017-03-21. FDA classified it as Class II and gives the reason as "In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data". 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-1830-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-21
Posted: 2017-04-17
Terminated: 2018-09-19
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: In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Root cause tag: software
FDA root cause: Software design
Action: A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation.
Quantity in commerce: 2 worldwide, 1 in U.S.
Distribution: Distribution in US (to Louisiana), and France.
Product codes and lots: Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1830-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1830-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-17

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)