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SagiNova® 25 channels, for Co-60 and Ir-192

BEBIG Medical GmbH · Model 06 · UDI-DI 04065983000023

JAQ Prescription

510(k) clearances

413

Adverse events

Recalls

Facilities

Description

SagiNova® is a family of BEBIG Medical (and Eckert & Ziegler BEBIG) HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote-controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.

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	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 GM11
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 issue
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.