Proton Therapy System Software Allows Safety Verification Mechanisms to Be Disabled
The IBA Proton Therapy System (PROTEUS 235 and related models) has a software defect allowing safety parameter verification mechanisms to be deactivated during clinical use. This affects 35 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a proton therapy system with a software defect allowing safety verification mechanisms to be deactivated during clinical use. Per the recall rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a severity score of 3.
Plain-English summary
The FDA has issued a Class II recall for the IBA Proton Therapy System, including PROTEUS 235 ProteusPLUS and ProteusONE models running affected software versions (PTS-8, PTS-10, PTS-11, and PTS-12). The recall affects 35 units distributed worldwide, including locations in multiple U.S. states and countries in Europe and Asia.
The software contains a defect that allows safety parameter verification mechanisms to be deactivated during clinical runtime. This could permit treatment parameters to proceed without the verification checks designed to ensure patient safety.
Affected facilities are located in the United States (Alaska, New Jersey, Pennsylvania, Virginia, Oklahoma, Florida, Kansas, Illinois, Louisiana, Michigan, Tennessee, and Texas) and internationally in Belgium, Czech Republic, Germany, Spain, France, India, Italy, Japan, Netherlands, Poland, Russia, Sweden, Singapore, and Taiwan.
The recalled product
- Product
- IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
- Manufacturer
- Ion Beam Applications S.A.
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 05404013801138 Serial Numbers: PAT.107 (DE)
- PAT.108 (US)
- PAT.109 (US)
- PAT.110 (US)
- PAT.111 (FR)
- PAT.112 (US)
- PAT.113 (US)
- PAT.114 (CZ)
- PAT.115 (IT)
- SAT.116 (US)
- SAT.117 (PL)
- SAT.118 (RU)
- SAT.119 (US)
- SAT.120 (DE)
- SAT.122 (SE)
- SAT.123 (US)
- SAT.125 (IN)
- SAT.126 (US)
- SAT.127 (TW)
- SAT.132 (NL)
Distribution
Related recalls
Same manufacturer · Ion Beam Applications S.A.
See all →- HighIBA proton therapy system may not interrupt beam when gating fails
FDA (Devices) · 2026-03-18
- HighIBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction
FDA (Devices) · 2024-08-28
- HighProton Therapy System May Continue Irradiation When Accelerator Control Parameters Out of Tolerance
FDA (Devices) · 2024-06-12
- HighProton Therapy System Recall: Safety Parameter Failures Risk Unintended Radiation
FDA (Devices) · 2024-05-01
- HighIBA Proton Therapy System Patient Positioning Can Move Unexpectedly
FDA (Devices) · 2023-11-22
Same hazard · safety bypass
See all →- HighHeNe laser system recalled for removable key safety control defect
FDA (Devices) · 2024-09-18
- SevereZeiss Laser Scanning Microscope Component Recalled for Laser Safety Bypass
FDA (Devices) · 2020-04-15
Similar recalls
- HighProton Therapy System Recall: Safety Parameter Failures Risk Unintended Radiation
FDA (Devices) · 2024-05-01
- HighIon Beam Applications Recalls Proteus 235 Proton Therapy Systems Due to Software Issue
FDA (Devices) · 2017-07-12
- ModerateIon Beam Applications Recalls Proteus Proton Therapy Systems for Software Issues
FDA (Devices) · 2017-07-12
- HighIBA proton therapy system may not interrupt beam when gating fails
FDA (Devices) · 2026-03-18
- HighIon Beam Applications Recalls Proteus 235 Proton Therapy Systems
FDA (Devices) · 2017-04-26
- HighIBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction
FDA (Devices) · 2024-08-28