Z-2684-2017Class II

Proteus 235, Proton Therapy System

Name: Z-2684-2017 Proteus 235, Proton Therapy System
Creator: Ion Beam Applications S.A.
Published: 2016-12-13
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2016-12-13 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for... on 2016-12-13. FDA classified it as Class II and gives the reason as "Software issue". 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-2684-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-13
Posted: 2017-07-04
Terminated: 2019-04-12
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Software issue
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Field Safety Notice was mailed to affected customers to inform them of the issue. The notice indicated possible software failure, the associated risks and actions users should implement to correct the issue. IBA plans to follow-up with a software update which will be deployed on impacted sites to correct this issue.
Quantity in commerce: 6 worldwide and 5 in the U.S.
Distribution: Distributed to FL, VA, IL, NJ, WA and South Korea
Product codes and lots: Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2684-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2684-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)