PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 15, 2021 Initiated: July 20, 2021 #Z-2437-2021

Product Description

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.

Details

Recalling Firm
Angiodynamics, Inc.
Units Affected
26 US, 4 OUS
Distribution
Domestic distribution Nationwide. Foreign distribution worldwide.
Location
Queensbury, NY

Frequently Asked Questions

What product was recalled?
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US. Recalled by Angiodynamics, Inc.. Units affected: 26 US, 4 OUS.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 15, 2021. Severity: Moderate. Recall number: Z-2437-2021.