Data Foundry

Medical device recalls 2021

Solero Generator PG — Class II medical device recall Z-2439-2021

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-2439-2021
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)
Quantity65 ous
Reason classessoftware
Serial numbersQBY0001991, QBY0001996, QBY0001999, QBY0002000, QBY0002004, QBY0002012, QBY0002014, QBY0002015, QBY0002036, QBY0002048, QBY0002058, QBY0002303, QBY0002346, QBY0002353, QBY0002355, QBY0002363, QBY0002368, QBY0002431, QBY0002432, QBY0002481, QBY0002510, QBY0002513, QBY0002531, QBY0002532, QBY0002563 and 40 more
Model numbers12740000, H78712740000

Product

Solero Generator PG, Item No. H78712740000, Catalog No. 12740000

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-2439-2021. 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.