Fletcher CT/MR Shielded Applicator Set
Elekta recalls Fletcher CT/MR Shielded Applicator Set over risk of intrauterine tube tip detachment.
Healthcare providers should immediately stop using the affected applicator sets, quarantine any remaining inventory, and contact Elekta for instructions on returning the devices for replacement or remediation.
Why it was recalled
Elekta is recalling the Fletcher CT/MR Shielded Applicator Set, an intracavitary remote afterloading applicator used for gynecological brachytherapy, due to the risk that the tip of the intrauterine tube may detach and remain inside a patient.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium. | 08717213024205 | Z-2710-2026 |
| Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy. | 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131 | Z-2711-2026 |
| Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy. | 08717213056039, 08717213056053, 08717213056077, 08717213056091, 08717213056398, 08717213056411, 08717213056435, 08717213056459, 08717213056473, 08717213056497, 08717213056510, 08717213056534, 08717213056558, 08717213056572, 08717213056596, 08717213056619, 08717213056633, 08717213056657 | Z-2712-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Elekta, Inc.
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification