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HDR MRI Lumen Marker

C4 IMAGING, LLC · Model F-01-02-0001 · UDI-DI 00863593000235

JAQ Prescription

510(k) clearances

413

Adverse events

Recalls

Facilities

Description

The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length. The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators.

Recalls

Date	Firm	Reason
2026-04-03	Elekta, Inc.	Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2026-04-03	Elekta, Inc.	Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2026-04-03	Elekta, Inc.	Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2019-11-18	Nucletron BV	A component failure may lead to treatment interruption or incorrect source positioning.
2015-05-18	Varian Medical Systems Inc	After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issu
2015-05-18	Varian Medical Systems Inc	Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM1
2013-08-09	Varian Medical Systems, Inc.	The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
2012-09-28	Varian Medical Systems, Inc.	The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
2012-04-12	Varian Medical Systems, Inc.	A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
2012-04-12	Varian Medical Systems, Inc.	A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.