Z-1205-2022Class II

Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with...

Name: Z-1205-2022 Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with...
Creator: Ion Beam Applications S.A.
Published: 2022-04-20
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2022-04-20 / Open, Classified

FDA source

Ion Beam Applications S.A. began a recall of Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to... on 2022-04-20. FDA classified it as Class II and gives the reason as "First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1205-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-20
Posted: 2022-05-27
Recalling firm: Ion Beam Applications S.A.
Product: Proteus235- Proton Therapy System: to produce and deliver 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: First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
FDA root cause: Under Investigation by firm
Action: ***UPDATE 12/22/22*** Ion Beam Application S.A. (IBA S.A.) issued an Amended Urgent Medical Device Correction to customers starting December 22, 2022 (supersedes previous letter Sept 15, 2022). Letter provides quantitative data about the impact on the dose distribution, and the description of the solution (software upgrade) as well as the time schedule for its deployment. Cyclic check thresholds verification and software upgrade Additionally, IBA will provide each impacted customer with a report including: - The list of the Uniform Scanning fields with the first layer entirely delivered with the tuning setpoints and a significant difference (above 0.3V) between the prescribed setpoints and the tuning setpoints, - The modelled maximum and average dose errors for these fields IBA will upgrade the PTS version to ensure that: - the irradiation of a layer cannot be started if the Scanning Magnet setpoints for the layer are not properly sent to the Scanning Magnet Power Supply, and - no setpoints request can be lost (even if previous requests are not yet executed or completed). The report including the identified impacted Uniform Scanning fields with the modelled maximum and average dose errors for these fields will be provided to each impacted customer by February 28, 2023. On the sites where IBA has not yet finalized the verification and the possible adaptation of the field size and dose rate cyclic check thresholds, this action will be completed by January 15, 2023. The PTS version upgrade will be deployed on your site by March 31, 2023. Contact: HEAD OF POST MARKET VIGILANCE Sonia PINEL [email protected] +32 10 497 516 ___________________________________________________________________________ **UPDATED 9/15/22*** The cause of these events has been identified as a software race condition between the different tasks that handle the Scanning Magnet Electronic Unit (SMEU). IBA CAPA PNC-543 has been opened. The root cause analysis is in progress. This recall re
Quantity in commerce: 4 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
Product codes and lots: UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1205-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1205-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-05-27

Product code LHN

K163500Class IIIBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A. / cleared 2017-08-17

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)