Elekta, Inc. recalls Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator…

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

On 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

• FDA enforcement recordOfficial FDA database entry for Z-2711-2026
• FDA 510(k) clearance · K161688The device's official FDA premarket clearance record
• FDA device classification · JAQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5700The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Elekta, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.