FDA recall Z-2437-2021

Angiodynamics, Inc. · Class II · device

Product

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

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.

Distribution

Domestic distribution Nationwide. Foreign distribution worldwide.

Key facts

Status
Terminated
Initiation date
2021-07-20
Report date
2021-09-15
Termination date
2023-03-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Queensbury, NY, United States

Primary source

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