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AOS Implant Tube
ALPHA-OMEGA SERVICES, INC. · Model TIS0002-002 · UDI-DI 00850645007205
10
510(k) clearances
413
Adverse events
52
Recalls
46
Facilities
Description
Implant Tube, Single Leader, Green Nylon, 28 cm Leader, 25 cm Body, Sealed End, with Nylon Retaining Buttons, 10 ea
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.