IBA recalls PROTEUS 235 proton therapy systems with specific versions due to risk of patient crushing during positioning. Affected units have unique serial numbers and software versions.
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
IBA is recalling specific versions of their PROTEUS 235 proton therapy systems because the patient positioning system might move unexpectedly, potentially crushing the patient. This is serious but only affects medical devices used in hospitals.
The patient positioning system can move unexpectedly in directions that weren't intended, which could cause the patient to be crushed between the positioning devices. This is a mechanical failure that could happen during treatment adjustments.
Hospitals and medical facilities using the affected PROTEUS 235 systems with specific serial numbers and software versions. Patients receiving treatment with these systems are at risk.
Check if your system has serial numbers like SAT133, SAT140, SBF113, SBF128, SBF135 (US) or SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, SBF125 (OUS). Also look for Orion PPS version OSS6.0 software.
Immediately cease operation of the affected PROTEUS 235 systems until a replacement is installed.
PTS-11 and PTS-12 versions with Orion PPS version OSS6.0 software, identified by specific serial numbers listed in the recall.
Check your system's serial numbers against the list provided: US serials SAT133, SAT140, SBF113, SBF128, SBF135 and OUS serials SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, SBF125.
The recall does not specify a fix; affected systems must be stopped immediately and replaced.
We’ve drafted a message you can send Ion Beam Applications to request your refund or repair — edit it as you like.
Subject: Recall Z-0295-2024 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-0295-2024 from Ion Beam Applications. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
