Elek: Recall of Fletcher CT/MR Shielded Applicator Set due to potential IU tube detachment after use. Affected units may cause retained tissue in patients.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Elekta is recalling its Fletcher CT/MR Shielded Applicator Set for gynecological brachytherapy. The recall is due to a risk that the intrauterine tube tip may detach and remain inside a patient, potentially causing retained tissue.
The applicator set may cause the intrauterine tube tip to detach during use. If the tip remains inside the patient, it could lead to retained tissue, which may require additional medical intervention.
Women undergoing gynecological brachytherapy treatment with the Fletcher CT/MR Shielded Applicator Set are most at risk. The specific product model is used for cervical and endometrial treatments.
The product is labeled 'Fletcher CT/MR Shielded Applicator Set' for gynecological brachytherapy. It was sold with lot code 08717213024205.
Look for the product name 'Fletcher CT/MR Shielded Applicator Set' and lot code 08717213024205.
The recall is due to safety concerns that the intrauterine tube tip may detach and remain inside a patient.
The official recall notice does not specify a remedy or action steps beyond checking the product label.
The recall mentions potential retained tissue, but the official notice does not describe a risk of serious injury or death.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-2710-2026 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-2710-2026 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.
