Z-1492-2014Class II

Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116...

Name: Z-1492-2014 Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116...
Creator: Ion Beam Applications S.A.
Published: 2013-12-04
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2013-12-04 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy on 2013-12-04. FDA classified it as Class II and gives the reason as "Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1492-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-04
Posted: 2014-04-24
Terminated: 2014-06-12
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
Root cause tag: software
FDA root cause: Software design
Action: Ion Beam Applications ( IBA) sent a recall notification letter dated on/about December 5, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Short term action: A user notice (see annex 1) has been sent to impacted sites where the affected legacy PTS software version was delivered. This user notice explains the workaround required to be put in place in order to fully mitigate the risk and the 1BA action plan to permanently fix this issue. Corrective action: A patch on the PTS Legacy SW was requested and in implementation. In the same time, the solution was put in main code of PTS legacy software version 7 to be integrated in the next release. The customer representative signing underneath confirms that the user notice above is communicated to the appropriate employees. We apologize in advance for any inconvenience this may cause and we would like to thank you for your cooperation. The IBA Site Staff or the Operations manager is available to provide you with additional information and/or guidelines if necessary. Further questions please call : 215-972-7777
Quantity in commerce: 4
Distribution: US Distribution including the states of OK, IL, NJ, and WA.
Product codes and lots: Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1492-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1492-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code LHN

K082416Class IIIba Proton Therapy System- Proteus 235Ion Beam Applications S.A. / cleared 2008-12-12

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)