Z-1695-2017Class II

Proteus 235

Name: Z-1695-2017 Proteus 235
Creator: Ion Beam Applications S.A.
Published: 2017-03-09
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2017-03-09 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235 on 2017-03-09. FDA classified it as Class II and gives the reason as "The Proton Therapy System can allow gantry rotation even if the snout is not properly locked". 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-1695-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-09
Posted: 2017-03-23
Terminated: 2019-03-26
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
Root cause tag: design
FDA root cause: Component design/selection
Action: A Field Safety Notice was mailed or handed to affected customers to inform them of the issue. The notice provides information on the issue, the risk for the patient and user and actions to be taken before starting gantry rotation. Corrective action developed by IBA are detailed.
Quantity in commerce: 8 worldwide, 4 in U.S.
Distribution: Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
Product codes and lots: Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1695-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1695-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-29

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)