Data Foundry

Medical device recalls 2021

Solero Generator Refurbished US PG — Class II medical device recall Z-2436-2021

Terminated recall by Angiodynamics, Inc., reported 2021-09-15, distributed nationwide. Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce t

Recall numberZ-2436-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAngiodynamics, Inc., Queensbury, NY, United States
Recall initiated2021-07-20
Classified2021-09-08
Reported by FDA2021-09-15
Terminated2023-03-15
DistributedNationwide (US)
Reason classessoftware
Serial numbersQBY0002379, QBY0002382, QBY0002398, QBY0002517, QBY0002525, QBY0002527, QBY0002546, QBY0002552, QBY0002561, QBY0002562, QBY0002567, QBY0002569, QBY0002580, QBY0002612, QBY0002669, QBY0002682, QBY0002708, QBY0002758
Model numbers12740000USD, H78712740000USD0

Product

Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2436-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.