Z-2592-2017Class II

Proteus 235

Name: Z-2592-2017 Proteus 235
Creator: Ion Beam Applications S.A.
Published: 2017-02-09
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2017-02-09 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235 on 2017-02-09. FDA classified it as Class II and gives the reason as "It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is...". 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-2592-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-09
Posted: 2017-06-19
Terminated: 2023-07-14
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
Root cause tag: design
FDA root cause: Device Design
Action: Ion Beam Application S.A. (IBA) will bring the defect into compliance: 1. Providing recommendations for user actions which, if followed, will prevent dark current. In order to prevent the error from occurring, the IBA customers are provided with a specific QA map that would detect dark current and instructions on how and when to use it (Annex 1). This guidance was included in IBAs User Notice which was sent to users on February 9, 2017. 2. IBA is developing a long term solution consisting of a new IC-cyclo (ionization chamber located at the cyclotron exit) and a Beam Absence Electronic Unit (BAEU) along with a software upgrade. This solution will detect presence of dark current between irradiations. It will prevent starting a new irradiation if dark current is present. This solution is currently in test phase and will be completed in two years. 3. Manufacturer will provide the FDA with progress reports on the effectiveness of the plan, including the number of electronic products repaired on a quarterly basis. The first progress report will be provided to the FDA by September 15, 2017 to the correspondence identified below. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions please call (571) 449-4992.
Quantity in commerce: 18 systems ( 10 in the US)
Distribution: Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
Product codes and lots: Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2592-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2592-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-19

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)