Fletcher CT/MR Shielded Applicator Set Intracavitary Remote Afterloading Applicator Product recall — FDA Z-2710-2026
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Overview of recall records associated with Elekta, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 6.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Due to adapter not being properly aligned or locked in place.
This page summarizes recall records in which the official source identifies Elekta, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.