Z-2711-2026Class II

Elekta, Inc.

Recalling firm

Elekta, Inc.

Product type

Device

Status

Ongoing

Report date

2026-07-15

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.

Firm state

Product quantity

586

Initiated by

Voluntary: Firm initiated

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.

Product description

Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

Code / lot info

Lot Code: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.