FDA recall Z-2437-2021

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