FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235-Proton Therapy System
- Recall number
- Z-2155-2021
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proteus 235-Proton Therapy System
- Status
- Open, Classified
- Initiated
- 2021-05-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
- Root cause
- Labeling design
- Action
- IBA issued Urgent Medical Device Correction notification starting on May 27, 2021. Letter states reason for recall, health risk and action to take: IBA would like to remind Proteus235 users of the following warning present in the Clinical User Guide: As a Radiation Therapy Technologist (RTT), check before allowing the irradiation that the position of the selector switch of the external beam triggering interface is consistent with the prescription data in the patient file. There is a risk of mistreatment as the system does not automatically detect the gating prescription thereby always generating a continuous irradiation. Labelling change and training IBA will: - update the user manuals to recommend the customers to define a procedure for patients with gating prescribed in order to ensure that the system will be set correctly, - provide user training sessions about the preparation of a treatment with UBTI synchronization. The actions will be performed for your site by December 31, 2021. Your IBA representative is able to provide you with additional information and/or guidelines if necessary.
- Quantity
- 5 US; 8 OUS
- Distribution
- FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
- Lot, serial or model codes
- Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).
- 510(k) numbers
- ["K101508"]
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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