FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
- Recall number
- Z-1492-2014
- 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
- Status
- Terminated
- Initiated
- 2013-12-04
- Posted
- 2014-04-24
- Terminated
- 2014-06-12
- Reason
- 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
- 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
- 4
- Distribution
- US Distribution including the states of OK, IL, NJ, and WA.
- Lot, serial or model codes
- Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.
- 510(k) numbers
- ["K082416"]
- PMA numbers
- not on file
- Product code
- LHN
- Firm FEI
- 3000256071
- Firm city
- Louvain La Neuve
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28