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CT/MR Applicator Clamp

Nucletron B.V. · Model 189932P01-04 · UDI-DI 08717213051645

JAQ Prescription
10
510(k) clearances
413
Adverse events
52
Recalls
46
Facilities

Description

CT/MR Applicator Clamp with Base Plate

Recalls

DateFirmReason
2026-04-03Elekta, Inc.Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2026-04-03Elekta, Inc.Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2026-04-03Elekta, Inc.Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2019-11-18Nucletron BVA component failure may lead to treatment interruption or incorrect source positioning.
2015-05-18Varian Medical Systems IncVarian 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
2015-05-18Varian Medical Systems IncAfter 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
2013-08-09Varian 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.
2012-09-28Varian Medical Systems, Inc.The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
2012-04-12Varian Medical Systems, Inc.A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
2012-04-12Varian 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.