Elekta, Inc.: Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometri

Hazard

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

Details from the source

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: 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 Quantity: 1317 Lot/code info: Lot Code: 08717213056039, 08717213056053, 08717213056077, 08717213056091, 08717213056398, 08717213056411, 08717213056435, 08717213056459, 08717213056473, 08717213056497, 08717213056510,08717213056534, 08717213056558, 08717213056572, 08717213056596, 08717213056619, 08717213056633, 08717213056657

UPC codes

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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.