Elekta recalls Unity MRI systems due to unvalidated use of gadolinium contrast agents in radiation therapy. Affected units may pose risks if contrast agents are administered without proper validation.
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
Elekta is recalling its Unity MRI systems used in radiation therapy because the manual does not warn about using gadolinium-based contrast agents. This could lead to safety issues if contrast agents are administered without proper validation.
The recall states that the manual lacks warnings for administering gadolinium-based contrast agents during MRI-guided radiation therapy. This could lead to unvalidated use, potentially causing safety risks if contrast agents are used without proper validation.
Medical professionals using Elekta Unity systems for radiation therapy treatments are most at risk. Patients receiving these treatments may also be affected if contrast agents are used without proper validation.
Check for the product codes UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, and other listed models. The UDI numbers 1536549 are also associated with these units.
Identify the specific product codes and UDI numbers listed in the recall notice to confirm if your unit is affected.
The recall occurs because the Elekta Unity manual does not include warnings for administering gadolinium-based contrast agents during radiation therapy, which could pose safety risks.
The official notice does not specify a remedy, so check the product details to see if your unit is affected and contact Elekta for further instructions.
The recall indicates a potential risk if gadolinium-based contrast agents are administered without proper validation, but the exact hazard severity is not clearly described.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1297-2019 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1297-2019 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.
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.
