Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product De

FDA device recall Z-2710-2026 · posted 2026-07-09 · Open, Classified

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

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

Action taken

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 Application.Support.NA@elekta.com Tel: +1 855 6935358 https://www.elekta.com Region Asia Pacific HK.TW.Support@elekta.com Tel: + 852 2891 2208 https://www.elekta.com Japan Japan-fco@elekta.com Tel: + 81 3 6722 3800 Fax: +81 3 6436 4231 https://www.elekta.com Region China FCO.CN@elekta.com Tel : + 86 800 810 2550 https://www.elekta.com Region Europe Support.europe@elekta.com Tel : + 46 8 587 254 00 https://www.elekta.com Region Turkey, India & Middle East support.rma@elekta.com Turkey Tel: +90 216 444 6374 India Tel: +1-800-103-7454 Middle East Tel: +00 800 4000 5000 https://www.elekta.com

Root cause

Process control

Status

Open, Classified

Product code

JAQ

Quantity affected

1

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,

Date initiated

2026-04-03

Date posted

2026-07-09

Location

Atlanta, GA

Related 510(k) clearances