FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1945-2024
·
Reported June 12, 2024
Enforcement
- Recall Number
- Z-1945-2024
- Event ID
- 94576
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ion Beam Applications S.A.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2024
- Initiation Date
- May 10, 2024
- Classification Date
- June 3, 2024
- Address
- Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, N/A, Belgium
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
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Code Info
UDI: SAT140: (01)05404013814015(11)190507(21)SAT140 SAT136: (01)05404013801138(11)201105(21)SAT136 Serial Numbers: SAT136, SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions, with C230 accelerator
Distribution
Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
Quantity
2 units