Z-2173-2018Class II

Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of...

Name: Z-2173-2018 Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of...
Creator: Ion Beam Applications S.A.
Published: 2016-08-07
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2016-08-07 / Terminated / root cause: manufacturing process

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions... on 2016-08-07. FDA classified it as Class II and gives the reason as "IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2173-2018
Classification: Class II
Status: Terminated
Initiated: 2016-08-07
Posted: 2018-06-12
Terminated: 2020-03-25
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235 The PTS 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: IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: IBA mailed out a Field Safety Notice on August 2, 2016, to affected customers where this maintenance is not performed by IBA technicians to inform them of the issue. For further questions please call (215) 972-7985.
Quantity in commerce: 19 units
Distribution: Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
Product codes and lots: Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.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-2173-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2173-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12

Product code LHN

K132919Class IIGantry Beam LineIon Beam Applications S.A. / cleared 2014-07-10

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)