Skip to content

Brand Name: Fletcher CT/MR Shielded Applicator Set recallZ-2710-2026 · Elekta, Inc. · initiated Apr 3, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

FDA root cause category: Process control

What the company is doing

On 04/03/2026, an "IMPORTANT FIELD SAFETY NOTIFICATION/URGENT: MEDICAL DEVICE CORRECTION" Letter was sent via email informing customers of a safety concern regarding detachment of the tip of an Intrauterine tube (IU tube) with a 4 mm diameter. Customers are instructed to: To prevent any potential health risks related to a detached tip, we emphasize the importance of adhering to the Instructions for Use: " Do not use an IU tube beyond its 3-year life expectancy or 300 reprocessing cycles, whichever comes first. " During the treatment preparation phase, before insertion of the applicator: Visually inspect parts for indication of damage, weakening, bending, cracks, corrosion, or general deterioration. " Inspect joints and connections on play, strength or other forms of degradation. In addition, we recommend the following: " Inspect the end of the IU tube to ensure that there is no gap between the tip and the fiber tube and that the tip is not detached. " During inspection, insertion and removal: avoid the use of excessive force that could damage the IU tube. " After removal: Ensure that all applicator parts have been removed from the patient and that the tip is not detached. In case you find a damaged or detached IU tube tip, remove it from clinical use and contact Elekta for a replacement. For Questions- Region America [email protected] Tel: +1 855 6935358 https://www.elekta.com Region Asia Pacific [email protected] Tel: + 852 2891 2208 https://www.elekta.com Japan [email protected] Tel: + 81 3 6722 3800 Fax: +81 3 6436 4231 https://www.elekta.com Region China [email protected] Tel : + 86 800 810 2550 https://www.elekta.com Region Europe [email protected] Tel : + 46 8 587 254 00 https://www.elekta.com Region Turkey, India & Middle East [email protected] Turkey Tel: +90 216 444 6374 India Tel: +1-800-103-7454 Middle East Tel: +00 800 4000 5000 https://www.elekta.com

Recall details

Recall number
Z-2710-2026
Status
Open, Classified
Initiated by the company
Apr 3, 2026
Posted by the FDA
Jul 9, 2026
Recalling firm
Elekta, Inc.
Quantity
1
Product code
JAQ
FDA submissions
K132889
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.

Product description

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.

Code information (models, lots, serial numbers)

Lot Code: 08717213024205

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98704).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page