Device recall

Z-2711-2026: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological…

FDA device recall · Class II · Elekta, Inc.

Key facts

Recall number (Z-number) Z-2711-2026
Recall event 98704
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…
Product code JAQ
Recalling firm Elekta, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K161688
FEI number 1037831

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)