Z-2711-2026Class II

Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The...

Name: Z-2711-2026 Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The...
Creator: Elekta, Inc.
Published: 2026-04-03
License: https://open.fda.gov/license/

Elekta Limited / initiated 2026-04-03 / Open, Classified / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological... on 2026-04-03. FDA classified it as Class II and gives the reason as "Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2711-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-03
Posted: 2026-07-09
Recalling firm: Elekta Limited
Product: 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.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] Tel: +1 855 6935358 https://www.elekta.com Region Asia Pacific [email protected] Tel: + 852 2891 2208 https://www.elekta.com Japan [email protected] Tel: + 81 3 6722 3800 Fax: +81 3 6436 4231 https://www.elekta.com Region China [email protected] Tel : + 86 800 810 2550 https://www.elekta.com Region Europe [email protected] Tel : + 46 8 587 254 00 https://www.elekta.com Region Turkey, India & Middle East [email protected] 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 commerce: 586
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.
Product codes and lots: Lot Code: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2711-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2710-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-09
Z-2711-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-09
Z-2712-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-09

Product code JAQ

K161688Class IIAdvanced Gynecological ApplicatorNucletron B.V. / cleared 2017-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)