Elekta recalls Harmony Pro and Infinity models due to risk of diode failure causing potential injury. Affected units have specific serial numbers and UDI codes.
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 Harmony Pro and Infinity linear accelerators because a diode can fail destructively when removed, potentially causing injury. This hazard affects specific models with known serial numbers and UDI codes.
The diode D1 in the modulator can fail destructively when removed from the machine. This failure may cause the protective tube to break, ejecting material that could cause injury.
Medical facilities using Elekta Harmony Pro or Infinity linear accelerators with the listed serial numbers are most at risk. Patients and staff near the equipment could be affected if the diode fails.
Check for Elekta Harmony Pro (serial #441009) or Infinity (serial #156645) with specific UDI codes listed in the recall notice. The Versa HD model (serials 156646, 156477, 156648) is also affected.
Identify your unit's serial number and UDI code to confirm if it's affected by this recall.
Elekta Harmony Pro (serial #441009), Infinity (serial #156645), and Versa HD (serials 156646, 156477, 156648) are affected.
The diode D1 in the modulator can fail destructively when removed, potentially causing injury if the protective tube fails.
No immediate stop is required, but you should check your serial numbers to confirm if your unit is affected.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0115-2022 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0115-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
