FDA-Device2021-09-15Class II

Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US

Angiodynamics, Inc.
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.

Sold states
Domestic distribution Nationwide. Foreign distribution worldwide.
Affected count
26 US, 4 OUS
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2437-2021

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