IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Reported: September 18, 2024 Initiated: July 8, 2024 #Z-3089-2024
Product Description
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Reason for Recall
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units Affected
- 35 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.
- Location
- Ottignies-Louvain-La-Neuve
Frequently Asked Questions
What product was recalled? ▼
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions. Recalled by Ion Beam Applications S.A.. Units affected: 35 units.
Why was this product recalled? ▼
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-3089-2024.
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