Accuray recalls CyberKnife VSI 9.6.x and Robotic Radiosurgery Systems for Japan with specific part numbers and serials due to risk of unintended collimator housing drop during housing exchanges.
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
Accuray is recalling CyberKnife VSI robotic radiosurgery systems for Japan with specific part numbers and serial numbers. The recall is due to a risk of unintended collimator housing dropping during certain maintenance procedures, which could lead to equipment malfunction.
During automated housing exchanges, the system may partially attach a collimator housing, causing it to drop unexpectedly. This could lead to equipment malfunction or unintended radiation exposure during treatment procedures.
Medical facilities in Japan using CyberKnife VSI 9.6.x or Robotic Radiosurgery Systems with the listed part numbers and serial numbers are most at risk. Patients receiving treatment with these systems may also be affected.
Check if your CyberKnife VSI system has part numbers 032500-010 (for 9.6.x systems) or 033000-010, and serial numbers listed in the recall notice for Japan. The affected units were sold in Japan between specific dates.
Verify your CyberKnife VSI system's part number and serial number against the list provided in the recall notice.
During automated housing exchanges, the system may partially attach a collimator housing, causing it to drop unexpectedly.
This recall applies only to medical facilities in Japan using the specified CyberKnife VSI systems.
Check your system's part number and serial number against the list of affected units provided in the recall notice.
We’ve drafted a message you can send Accuray to request your refund or repair — edit it as you like.
Subject: Recall Z-1697-2019 — Accuray Accuray Hello, I own a Accuray that is covered by recall Z-1697-2019 from Accuray. 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.
