Ion Beam Applications recalls Proteus 235 proton therapy systems where user signatures longer than 10 characters prevent resuming aborted treatments. This medical device affects specific models manufactured between May and November 2019.
Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS position is changed for the next session in the OIS. This includes the partial continuation session. Therefore, when comparing the prescribed PPS position between OIS and local database, the PTS sees a difference and rejects the local partial archive. This problem forces the user to resume the interrupted irradiation based on the overall delivered dose displayed on the DCEU instead of resuming from the full details of the interrupted beam.
Ion Beam Applications is recalling Proteus 235 proton therapy systems because user signatures longer than 10 characters can prevent doctors from resuming interrupted treatments. This issue affects medical devices used for cancer treatment that were manufactured between May and November 2019.
The system requires user signatures to resume interrupted treatments, but signatures longer than 10 characters prevent this action. This can cause treatment interruptions to persist when the system displays the overall delivered dose instead of using full treatment details. The issue also affects electronic medical records and patient positioning systems.
Medical professionals using Proteus 235 proton therapy systems for cancer treatment. Patients receiving treatment with these systems may be affected if their doctors encounter signature length issues during treatment interruptions.
Check for the Proteus 235 system with brand names Proteus Plus or Proteus ONE. These devices were manufactured between May 2019 (US) and November 2019 (EU) with serial numbers starting with SAT.140 or SBF.112 through SBF.117.
Verify if your user signature exceeds 10 characters, which may prevent resuming interrupted treatments.
The Proteus 235 system requires user signatures to resume interrupted treatments, but signatures longer than 10 characters prevent this action, causing treatment interruptions to persist.
If your signature exceeds 10 characters, the system may not allow resuming interrupted treatments, requiring you to restart based on the overall delivered dose instead of using full treatment details.
Check if your user signature exceeds 10 characters; if so, contact your medical facility to resolve the issue before resuming treatments.
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-2773-2020 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-2773-2020 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.
