Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is inten
- Recall date
- 2026-07-15
- Brand
- Elekta, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Product description
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Affected products
Lot Code: 08717213056039, 08717213056053, 08717213056077, 08717213056091, 08717213056398, 08717213056411, 08717213056435, 08717213056459, 08717213056473, 08717213056497, 08717213056510,08717213056534, 08717213056558, 08717213056572, 08717213056596, 08717213056619, 08717213056633, 08717213056657