Elekta recalls Unity radiation therapy systems due to QA software not displaying MR to MV offset values, risking treatment errors. Affected units include specific model numbers and installation dates.
The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
Elekta is recalling its Unity radiation therapy systems because the quality assurance software fails to show stored magnetic resonance to megavoltage offset values. This means users cannot independently check these critical alignment values during quality assurance checks, potentially leading to treatment errors.
The QA software does not display stored magnetic resonance to megavoltage offset values. This prevents users from independently inspecting these values during quality assurance checks, which are critical for ensuring accurate radiation treatment alignment.
Medical facilities using Elekta Unity systems for radiation therapy treatments are most affected. Patients receiving treatment with these systems may be at risk if alignment values are not properly verified.
Check for the specific model numbers listed in the recall notice: UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, and other installed product codes. These units were installed with specific serial numbers and dates.
Verify if the QA software shows stored magnetic resonance to megavoltage offset values during quality assurance checks.
The recall affects medical facilities using the system, not patients directly. Patients receive treatment as usual unless the facility follows the recall steps.
Check for the specific model numbers listed in the recall notice: UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, and other installed product codes.
The recall does not require immediate action. Users should check if the QA software displays the stored offset values during quality assurance checks.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1980-2019 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1980-2019 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.
