Z-2672-2017Class II

Proteus 235 and Proteus ONE proton therapy systems

Name: Z-2672-2017 Proteus 235 and Proteus ONE proton therapy systems
Creator: Ion Beam Applications S.A.
Published: 2016-05-18
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2016-05-18 / Terminated / root cause: manufacturing process

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235 and Proteus ONE proton therapy systems on 2016-05-18. FDA classified it as Class II and gives the reason as "Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures". 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-2672-2017
Classification: Class II
Status: Terminated
Initiated: 2016-05-18
Posted: 2017-07-03
Terminated: 2019-02-08
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235 and Proteus ONE proton therapy systems
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An Urgent Field Safety Notice MID-54097 was mailed to affected customers to inform that IBA plans to deploy a new software by March 2017 to correct the issue. Customers were reminded to follow standard protocol until the software updates are deployed.
Quantity in commerce: 18 worldwide and 10, in the U.S.
Distribution: Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
Product codes and lots: Code/Serial Numbers: 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 and SAT.126

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2672-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2672-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03

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)