AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG
Medical device recall Z-1700-2019. Published in FDA’s Enforcement Report on Jun 12, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 12, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 314 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
314 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: (1) QBY0002022 QBY0001996 QBY0001997 QBY0002018 QBY0002303 QBY0002031 QBY0002020 QBY0002032 QBY0002016 QBY0002208 QBY0002017 QBY0002019 QBY0001990 QBY0002000 QBY0001989 QBY0001991 QBY0001995 QBY0001992 QBY0002024 QBY0001998…
Every code shown here, 2,000 characters
Serial Numbers: (1) QBY0002022 QBY0001996 QBY0001997 QBY0002018 QBY0002303 QBY0002031 QBY0002020 QBY0002032 QBY0002016 QBY0002208 QBY0002017 QBY0002019 QBY0001990 QBY0002000 QBY0001989 QBY0001991 QBY0001995 QBY0001992 QBY0002024 QBY0001998 QBY0001999 QBY0002023 QBY0002012 QBY0002013 QBY0002009 QBY0002015 QBY0002014 QBY0002005 QBY0002011 QBY0002045 QBY0002046 QBY0002047 QBY0002048 QBY0002049 QBY0002050 QBY0002210 QBY0002209 QBY0002057 QBY0002304 QBY0002302 QBY0002308 QBY0002309 QBY0002307 QBY0002351 QBY0002350 QBY0002353 QBY0002349 QBY0002355 QBY0002354 QBY0002357 QBY0002346 QBY0002344 QBY0002345 QBY0002358 QBY0002348 QBY0002356 QBY0002369 QBY0002371 QBY0002372 QBY0002370 QBY0002368 QBY0002364 QBY0002365 QBY0002363 QBY0002427 QBY0002359 QBY0002362 QBY0002360 QBY0002432 QBY0002430 QBY0002428 QBY0002431 QBY0002433 QBY0002434 QBY0002479 QBY0002480 QBY0002481 QBY0002510 QBY0002511 QBY0002512 QBY0002513 QBY0002514 QBY0002523 QBY0002530 QBY0002531 QBY0002532 QBY0002533 QBY0002563 QBY0002564 QBY0002565 QBY0002566 QBY0002571 QBY0002572 QBY0002573 QBY0002574 QBY0002575 QBY0002576 QBY0002622 QBY0002623 QBY0002624 QBY0002625 QBY0002626 QBY0002627 QBY0002629 QBY0002630 QBY0002631 QBY0002651 QBY0002652 QBY0002653 QBY0002655 QBY0002656 QBY0002657 QBY0002658 QBY0002659 QBY0002660 QBY0002661 QBY0002672 QBY0002673 QBY0002674 QBY0002675 QBY0002676 QBY0002677 QBY0002678 QBY0002679 QBY0002680 QBY0002694 QBY0002699 QBY0002700 QBY0002701 QBY0002702 QBY0002703 QBY0002709 QBY0002712 QBY0002713 QBY0002714 QBY0002715 QBY0002716 QBY0002717 QBY0002718 QBY0002731 QBY0002732 QBY0002733 QBY0002744 QBY0002745 QBY0002746 QBY0002743 QBY0002739 QBY0002737 QBY0002738 QBY0002734 QBY0002735 QBY0002736 QBY0002776 QBY0002777 QBY0002837 QBY0002779 QBY0002780 QBY0002782 QBY0002783 QBY0002784 QBY0002785 QBY0002786 QBY0002788 QBY0002789 QBY0002790 QBY0002791 QBY0002792 QBY0002793 QBY0002794 QBY0002796 QBY0002797 QBY0002810 QBY0002823 QBY0002824 QBY0002821 QBY0002822 QBY0002816 QBY0002817 QBY0002819 QBY0002814…
FDA’s list runs to 3,775 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide distribution and countries of AE AT AU BE CA CH CL CO CZ DE DK DZ EG ES FR GB GE GR HK IE IL IN IQ IT LB LT MC MT MX NL NZ PL PT SG TH TR TW VN ZA
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 17, 2019.
- FDA classified it on May 31, 2019.
- FDA’s Enforcement Report published it on Jun 12, 2019.
- FDA terminated it on Jun 9, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Angiodynamics Inc. (Navilyst Medical Inc.), of Glens Falls, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,775 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.