IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
Ion Beam Applications S.A. · Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Open FDA's page for this record- Cfres ID
- 207610
- Product res number
- Z-1945-2024
- Event date initiated
- 2024-05-10
- Event date posted
- 2024-06-03
- Recall status
- Open, Classified
- Res event number
- 94576
- Product code
- LHN
- Firm FEI number
- 3000256071
- Recalling firm
- Ion Beam Applications S.A.
- Address 1
- Chemin Du Cyclotron 3 3 chemin du cyclotron
- City
- Ottignies-Louvain-La-Neuve
- Country
- Belgium
- Additional info contact
- SAME 104758811
- Reason for recall
- Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
- Root cause description
- Device Design
- Product quantity
- 2 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
- 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.
- 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
- Action
Iba issued Urgent Medical Device Correction Letter on May 10, 2024 via IBA responsible directly to customer site either by hand or by email. Letter states reason for recall, health risk and action to take: ACTION BEING TAKEN BY IBA Monitoring of the deflector, software upgrade. 7.2 CORRECTIVE ACTIONS Software upgrade 7.3 PREVENTIVE ACTIONS Waiting for the solution to be deployed, IBA will distribute an Internal User Notice to IBA operators of impacted sites with instructions to monitor the deflector and stop the irradiation when necessary. 7.4 TIME SCHEDULE FOR THE IMPLEMENTATION OF THE DIFFERENT ACTIONS The Internal User Notice will be provided to IBA operators by May 10, 2024. The corrective action will be implemented at your site by June 2025. Contact: Sonia PINEL Vigilance@iba-group.com
- K numbers
- K163500
- Harmonized identifiers (openFDA)
- Device name
- System, Radiation Therapy, Charged-Particle, Medical
- Medical specialty description
- Radiology
- Regulation number
- 892.5050
- Device class
- 2
- K number
- K891261, K132919, K162246, K170719, K160612, K161163, K100766, K151132, K232032, K983342, K133191, K130426, K972212, K112768, K071399, K220883, K852907, K132847, K163500, K120676, K181789, K160063, K260174, K231863, K133914, K200282, K191821, K061913, K191521, K082416, K032511, K992414, K983332, K972211, K062891, K092796, K181498, K851301, K002194, K061051 +53 more
- Registration number
- 2247992, 8043933, 2916710, 3006579682, 3009754495, 9613183, 9681124, 1062572, 3010658895, 3010726836, 2953704, 3003993895, 1721113, 2032229, 3000256071, 3005374502, 3007087027, 9614952, 3015178562, 3004977335, 1000162206, 3008317830, 3015232217, 3016872563, 3042022819, 1038814, 8031557
- FEI number
- 3006653576, 2916710, 3006579682, 3009754495, 3007360740, 3003166990, 3010658895, 3010726836, 3002619595, 1270485, 1000227792, 3003993895, 1721113, 3000256071, 3007087027, 3015178562, 3001238439, 1000208827, 3004977335, 1000162206, 3001874253, 3008328959, 3015232217, 3016872563, 3042022819, 1038814, 3008317830