Elekta, Inc.: System, Applicator, Radionuclide, Remote-controlled
Summary Elekta's Geneva brachytherapy applicators used to treat cervical and endometrial cancer are being recalled because the tip of the intrauterine tube can detach and remain inside patients. The recall affects the devices distributed across the United States and numerous countries worldwide.
- Recalling firm
- Elekta, Inc.
- Product
- 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.
- Reason
- Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-03
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1b3ed27e-f7b6-447f-a25c-515b5d352d10