Elekta recalls specific medical linear accelerators due to risk of diode failure when removed, potentially causing injury. Affected models include Precise Digital, Harmony, Synergy, Infinity, and Versa HD systems.
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Elekta is recalling certain medical linear accelerators because a diode inside the machine can fail dangerously when removed, possibly causing injury. This recall affects specific models used in cancer treatment facilities.
The diode D1 in the modulator can fail destructively when removed from the machine. If the protective tube fails to contain ejected material, it could cause injury to personnel or patients.
Healthcare facilities using Elekta medical linear accelerators configured as Precise Digital, Harmony, Synergy, Infinity, or Versa HD are most at risk. Patients receiving treatment with these systems may be affected.
Check if your machine is listed as Precise Digital, Harmony, Synergy, Infinity, or Versa HD. Look for specific model numbers and serial numbers provided in the recall notice.
Identify your machine's model number and serial number to confirm if it is affected by this recall.
Reach out to Elekta directly for guidance on next steps and potential remedies.
This recall affects medical linear accelerators used in cancer treatment facilities. Patients receiving treatment with affected machines should contact their healthcare provider.
Healthcare facilities should check if their equipment is listed in the recall and contact Elekta for specific instructions.
Check if your machine is listed as Precise Digital, Harmony, Synergy, Infinity, or Versa HD with the specific model numbers and serial numbers provided in the recall notice.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0116-2022 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0116-2022 from Elekta. 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.
