MEDICAL DEVICE RECALLMODERATE

Fletcher CT/MR Shielded Applicator Set

Elekta recalls Fletcher CT/MR applicator set due to risk of IU tube tip detachment.

What to do

If you have a Fletcher CT/MR Shielded Applicator Set, stop using it immediately and contact Elekta for instructions on returning the device and obtaining a replacement.

Recalled

2026-04-03

Listed

2026-07-09

Updated

2026-09-08

Recall No.

Z-2710-2026

Agency

FDA

Firm

Elekta, Inc.

Recall ID

98704

Status

ONGOING

Why it was recalled

Elekta is recalling the Fletcher CT/MR Shielded Applicator Set, an intracavitary remote afterloading applicator used for gynecological brachytherapy, because the tip of the intrauterine tube (IU tube) may detach and remain within a patient. This poses a risk of injury or complications.

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	Recall #	UDI-DI
Fletcher CT/MR Shielded Applicator Set Intracavitary Remote Afterloading Applicator	Z-2710-2026	08717213024205
Brachytherapy Applicator Advanced Gynecological Applicator	Z-2711-2026	08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131
Geneva Brachytherapy Applicator	Z-2712-2026	08717213056039, 08717213056053, 08717213056077, 08717213056091, 08717213056398, 08717213056411, 08717213056435, 08717213056459, 08717213056473, 08717213056497, 08717213056510, 08717213056534, 08717213056558, 08717213056572, 08717213056596, 08717213056619, 08717213056633, 08717213056657

Where it was sold

Distributed nationwide.

Timeline

2026-04-03Firm initiated recall
2026-07-09Publicly announced
2026-07-10Listed on Recall Canary
2026-09-08Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

DermaV Laser System
[FDA] · 2026-09-04 · Lutronic Corporation
HeartSine Samaritan Pads
[FDA] · 2026-09-04 · HeartSine Technologies Ltd
GRANUFLO Dry Acid Concentrate
[FDA] · 2026-09-03 · Fresenius Medical Care Renal Therapies Group, LLC (3 products)
Fresenius 5008X Blood Tubing Set
[FDA] · 2026-09-02 · Fresenius Medical Care Renal Therapies Group, LLC (4 products)
Philips Brilliance CT Systems
[FDA] · 2026-09-01 · Philips North America Llc (4 products)
HEALON EndoCoat PRO and DUET PRO II
[FDA] · 2026-08-31 · Johnson & Johnson Surgical Vision, Inc.
STA Staclot Protein S
[FDA] · 2026-08-28 · Diagnostica Stago, Inc.
IMRIS ORT200 Operating Room Table
[FDA] · 2026-08-26 · IMRIS Imaging Inc (2 products)
healthmark ProChek-II Test
[FDA] · 2026-08-26 · Healthmark Industries Co., Inc. (2 products)
GENESYS CrossFT Suture Anchor
[FDA] · 2026-08-26 · ConMed Corporation

Other recent recalls from Elekta, Inc.

MOSAIQ Oncology Information System
[FDA] · 2026-06-11 · Elekta, Inc.
Leksell Vantage Arc System
[FDA] · 2026-04-29 · Elekta, Inc.
Leksell Gamma Knife Radiosurgery System
[FDA] · 2026-03-19 · Elekta, Inc.

All recalls from Elekta, Inc.

← Back to all recalls

Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification