Recall Z-2710-2026 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Elekta, Inc.
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.
| Date | Jul 9, 2026 (initiated Apr 3, 2026) |
| Status | Open, Classified |
| Reason | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. |
| Root cause | Process control |
| Action | 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: Visua |
| Quantity | 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, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) Nucletron B.V., Feb 26, 2014 |