Home / Recalls / Elekta, Inc. / Z-2712-2026

Z-2712-2026 Class II Ongoing

Recalled by Elekta, Inc. — Atlanta, GA

FDA device recall Z-2712-2026 was initiated by Elekta, Inc. on April 3, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1317.

Recall Details

Product Type: Devices
Report Date: July 15, 2026
Initiation Date: April 3, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1317

Product Description

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 for Recall

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

Distribution Pattern

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.

Code Information

Lot Code: 08717213056039, 08717213056053, 08717213056077, 08717213056091, 08717213056398, 08717213056411, 08717213056435, 08717213056459, 08717213056473, 08717213056497, 08717213056510,08717213056534, 08717213056558, 08717213056572, 08717213056596, 08717213056619, 08717213056633, 08717213056657

Other recalls by Elekta, Inc.

Z-2406-2026 Class II — MOSAIQ Oncology Information System (May 21, 2026)
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Z-2710-2026 Class II — Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary (April 3, 2026)
Z-2006-2026 Class II — Brand Name: Leksell Vantage Arc System REF: 1053958 (March 19, 2026)
Z-1581-2026 Class II — Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfe (February 18, 2026)
Z-1164-2026 Class II — Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Ele (December 14, 2025)
Z-1339-2026 Class II — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning (December 12, 2025)
Z-1340-2026 Class II — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning (December 12, 2025)
Z-1078-2026 Class II — MOSAIQ Oncology Information System with Particle Therapy License (License Kit 4 (December 10, 2025)
Z-0433-2026 Class II — Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotac (September 30, 2025)