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Lower risk Medical device recall · FDA · Published July 20, 2021

Angiodynamics Solero Generator: Error 0001 Software Update Needed

Angiodynamics recalls Solero MTA Generator units with specific serial numbers requiring software update to prevent Error 0001 during startup. Affected units must be serviced by authorized technicians.

🇺🇸 FDA recall #Z-2437-2021Medical deviceAngiodynamics ›
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Recalling firmAngiodynamics, Inc.603 Queensbury Ave · Queensbury, NY 12804-7619
✎ GovInfoNow plain-language explainer

Angiodynamics is recalling specific Solero MTA Generator units that need a software update to prevent Error 0001 during startup. This update helps reduce the chance of the error occurring, which could cause system issues. Read more at govinfonow.com/recall/62185-angiodynamics-solero-generator-error-0001-software-update-needed.

Source Summary by GovInfoNow · govinfonow.com/recall/62185-angiodynamics-solero-generator-error-0001-software-update-needed · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2437-2021

Cite this page

“Angiodynamics Solero Generator: Error 0001 Software Update Needed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62185-angiodynamics-solero-generator-error-0001-software-update-needed. Based on FDA recall #Z-2437-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2437-2021%22&limit=1).

The FDA announced on July 20, 2021, that Angiodynamics, Inc. is recalling specific Solero Generator US PG units to upgrade software and reduce Error 0001 incidents during system start-up. Owners must contact the company for servicing.

How to tell if you have it

  • Brand: Angiodynamics
  • Product: Solero Generator US PG
  • Item No.: H78712740000US0
  • Catalog No.: 12740000US
  • Serial Nos.: QBY0002693, QBY0002376, QBY0002765, QBY0002380, QBY0002763, QBY0002662, QBY0002570, QBY0002683, QBY0002551, QBY0002618, QBY0002006, QBY0002293, QBY0002578, QBY0002666, QBY0002378, QBY0002375, QBY0002283, QBY0002539, QBY0002762, QBY0002681, QBY0002690, QBY0002389, QBY0002518, QBY0002670, QBY0002395, QBY0002687, QBY0002613, QBY0002664, QBY0002759, QBY0002780

The hazard

Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.

Context

GovInfoNow's records show Angiodynamics, Inc. has 18 other recalls on record since June 5, 2017. Other recent recalls include the Soft-Vu Angiographic Catheter recall from March 3, 2026, and the IsoLoc Prostate Balloon Kit recall from Feb. 4, 2025.

How to tell if you have this one

Check the serial number on your Solero MTA Generator. Affected units have specific serial numbers listed in the recall notice, such as QBY0002693 or QBY0002376.

  • Brand
    Angiodynamics
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Domestic distribution Nationwide. Foreign distribution worldwide.
Recall numberProduct, codes & lotsQuantity
Z-2436-2021Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD; Serial Nos. QBY0002546 QBY0002517 QBY0002525 QBY0002562 QBY0002669 QBY0002569 QBY0002382 QBY0002682 QBY0002561 QBY0002567 QBY0002580 QBY0002398 QBY0002379 QBY0002612 QBY0002708 QBY0002527 QBY0002758 QBY000255216 US, 2 OUS
Z-2437-2021Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US; Serial Nos. QBY0002693 QBY0002376 QBY0002765 QBY0002380 QBY0002763 QBY0002662 QBY0002570 QBY0002683 QBY0002551 QBY0002618 QBY0002006 QBY0002293 QBY0002578 QBY0002666 QBY0002378 QBY0002375 QBY0002283 QBY0002539 QBY0002762 QBY0002681 QBY0002690 QBY0002389 QBY0002518 QBY0002670 QBY0002395 QBY0002687 QBY0002613 QBY0002664 QBY0002759 QBY000278026 US, 4 OUS
Z-2438-2021Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D; Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY00028588 OUS
Z-2439-2021Solero Generator PG, Item No. H78712740000, Catalog No. 12740000; Serial Nos. QBY0002623 QBY0002629 QBY0002857 QBY0002830 QBY0002843 QBY0002431 QBY0002715 QBY0002717 QBY0002731 QBY0002732 QBY0002744 QBY0002745 QBY0002363 QBY0002631 QBY0002834 QBY0001999 QBY0002000 QBY0002303 QBY0002353 QBY0002368 QBY0002432 QBY0002575 QBY0002653 QBY0002782 QBY0002783 QBY0002784 QBY0002004 QBY0002346 QBY0002576 QBY0002655 QBY0002680 QBY0002694 QBY0002709 QBY0002712 QBY0002791 QBY0002794 QBY0001991 QBY0001996 QBY0002036 QBY0002058 QBY0002703 QBY0002826 QBY0002833 QBY0002510 QBY0002624 QBY0002048 QBY0002012 QBY0002015 QBY0002481 QBY0002513 QBY0002531 QBY0002532 QBY0002812 QBY0002821 QBY0002738 QBY0002739 QBY0002564 QBY0002656 QBY0002657 QBY0002676 QBY0002014 QBY0002355 QBY0002563 QBY0002630 QBY000274365 OUS
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Angiodynamics to confirm if your unit is affected and schedule a software update.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic distribution Nationwide. Foreign distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Jul 20, 202112. FDA classified it Class II: Sep 8, 202123. Published in FDA’s Enforcement Report: Sep 15, 202134. FDA terminated the recall: Mar 15, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using my Solero Generator?

No, the recall requires a software update, not immediate discontinuation of use.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2437-2021 (July 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2437-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA