Z-1477-2018Class II

Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients...

Name: Z-1477-2018 Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients...
Creator: Ion Beam Applications S.A.
Published: 2018-01-26
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2018-01-26 / Terminated

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions... on 2018-01-26. FDA classified it as Class II and gives the reason as "When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1477-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-26
Posted: 2018-10-11
Terminated: 2020-04-27
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235, ProteusPLUS or Proteus ONE produces and delivers 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: When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
FDA root cause: Under Investigation by firm
Action: On January 26, 2018, the firm sent Field Safety Notices to all its consignees by email or delivered personally, alerting them of the issue. The notice recommended that users not resume pauses in Uniform Scanning more than twice without informing on-site firm personnel. The firm also recommended rebooting the Scanning Magnets Power Supply Electronic Unit if the issue occurs. The recalling firm stated it would implement an upgrade of the Scanning Magnet Power Supply Electronic Unit at all affected sites by June 30, 2018. Consignees were instructed to sign and return a copy of a notice read confirmation within 10 working days. Recalling firm Helpdesk Contact: +32 2 507 20 81 (available 24/7)
Quantity in commerce: 5
Distribution: Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.
Product codes and lots: Affected version: PTS-7.X.X and PTS-8.X.X Serial numbers PAT.107 (EU); PAT.108, PAT.112, PAT.113, PAT.116 (US)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1477-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1477-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20

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)