IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reported: June 12, 2024 Initiated: May 10, 2024 #Z-1945-2024
Product Description
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason for Recall
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units Affected
- 2 units
- Distribution
- Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
- Location
- Ottignies-Louvain-La-Neuve, N/A
Frequently Asked Questions
What product was recalled? ▼
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.. Recalled by Ion Beam Applications S.A.. Units affected: 2 units.
Why was this product recalled? ▼
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2024. Severity: Moderate. Recall number: Z-1945-2024.
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