Z-0930-2018Class II

Proteus 235, graphite block 8

Name: Z-0930-2018 Proteus 235, graphite block 8
Creator: Ion Beam Applications S.A.
Published: 2017-10-17
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2017-10-17 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235, graphite block 8 on 2017-10-17. FDA classified it as Class II and gives the reason as "IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader". 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-0930-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Posted: 2018-03-08
Terminated: 2019-03-29
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235, graphite block 8
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
Root cause tag: design
FDA root cause: Component design/selection
Action: On July 17, 2017 An Urgent Field Safety Notice was issued to customers with the following user action: In case a patient treatment plan requires the use of the block 8, it is recommended to perform a full range verification during the patient treatment plan QA check. After the replacement of the graphite block 8, it is recommended to verify there is no effect on the Bragg peak.
Quantity in commerce: 3
Distribution: WA
Product codes and lots: PAT.115, SAT.116

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0930-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0930-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-08

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)