I2C (IBA Image-Guided Therapy Console) adaPTinsightRecalls & reported problems
Ion Beam Applications SA · Image-Guided Therapy Console · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05404013830923), received between Nov 30, 2018 and Nov 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Malposition of Device” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Malposition of Device1
- Positioning Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2018Malposition of Device; Malposition of Device; Positioning Problem
IBA HAS BEEN INFORMED THAT ON (B)(6) 2018 DURING DAILY CHECKS PERFORMED ON THE SYSTEM, AN UNEXPECTED SHIFT IN POSITION OF A PHANTOM INSTALLED ON THE PATIENT POSITIONING SYSTEM WAS OBSERVED. THE PROCESSING UNIT WAS POWER CYCLED AND ADAPT INSIGHT WORKSTATION WAS RESTARTED. AFTERWARDS, THE SAME TEST AS ABOVE WAS PERFORMED AND THIS TIME THE PHANTOM WAS STILL ALIGNED PROPERLY. NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 8120233 ↗
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- Proteus 235 Proteus PLUSIon Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical1 recall1 report
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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