Home / Recalls / Ion Beam Applications S.A. / Z-1945-2024

Z-1945-2024 Class II Ongoing

Recalled by Ion Beam Applications S.A. — Ottignies-Louvain-La-Neuve, N/A

Recall Details

Product Type
Devices
Report Date
June 12, 2024
Initiation Date
May 10, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

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

Distribution Pattern

Worldwide - US Nationwide distribution in the state of Virginia and the country of India.

Code Information

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

Other recalls by Ion Beam Applications S.A.

  • Z-1497-2026 Class II — IBA Proton Therapy System - PROTEUS 235 (February 3, 2026)
  • Z-2693-2024 Class II — IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proto (July 10, 2024)
  • Z-3089-2024 Class II — IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software v (July 8, 2024)
  • Z-1603-2024 Class II — IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and P (March 4, 2024)
  • Z-0295-2024 Class II — IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with O (September 18, 2023)
  • Z-1205-2022 Class II — Proteus235- Proton Therapy System: to produce and deliver a proton beam for the (April 20, 2022)
  • Z-0747-2022 Class II — ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for th (February 15, 2022)
  • Z-0466-2022 Class II — Proteus 235; Version: PTS-8 versions before PTS-8.7.2 (November 29, 2021)
  • Z-2434-2021 Class II — Proteus 235- designed to produce and deliver a proton beam for the treatment of (June 14, 2021)
  • Z-2155-2021 Class II — Proteus 235-Proton Therapy System (May 26, 2021)