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Advanced Gynecological Applicator
Nucletron B.V. · Model 126022-00 · UDI-DI 08717213050488
JAQ
Prescription
1
510(k) clearances
413
Adverse events
52
Recalls
46
Facilities
Description
Intrauterine Tube 60mm 15°
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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Get your free API keyRead the docsData 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.