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U.S. Department of Health and Human Services

Class 2 Device Recall Brachytherapy Applicator

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 Class 2 Device Recall Brachytherapy Applicatorsee related information
Date Initiated by FirmApril 03, 2026
Date PostedJuly 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2711-2026
Recall Event ID 98704
510(K)NumberK161688 
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
ProductBrand 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 Information Lot Code: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131
FEI Number 1037831
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information ContactElekta Care Support
001-855-6935358
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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: Visually inspect parts for indication of damage, weakening, bending, cracks, corrosion, or general deterioration. " Inspect joints and connections on play, strength or other forms of degradation. In addition, we recommend the following: " Inspect the end of the IU tube to ensure that there is no gap between the tip and the fiber tube and that the tip is not detached. " During inspection, insertion and removal: avoid the use of excessive force that could damage the IU tube. " After removal: Ensure that all applicator parts have been removed from the patient and that the tip is not detached. In case you find a damaged or detached IU tube tip, remove it from clinical use and contact Elekta for a replacement. For Questions- Region America Application.Support.NA@elekta.com Tel: +1 855 6935358 https://www.elekta.com Region Asia Pacific HK.TW.Support@elekta.com Tel: + 852 2891 2208 https://www.elekta.com Japan Japan-fco@elekta.com Tel: + 81 3 6722 3800 Fax: +81 3 6436 4231 https://www.elekta.com Region China FCO.CN@elekta.com Tel : + 86 800 810 2550 https://www.elekta.com Region Europe Support.europe@elekta.com Tel : + 46 8 587 254 00 https://www.elekta.com Region Turkey, India & Middle East support.rma@elekta.com Turkey Tel: +90 216 444 6374 India Tel: +1-800-103-7454 Middle East Tel: +00 800 4000 5000 https://www.elekta.com
Quantity in Commerce586
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAQ
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