FDA DeviceClass IINotable

FDA Recall: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Descr

Date: 2026-07-15
Brand: Elekta, Inc.
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

586

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