RecallRadar

FDA Device recall Z-2438-2021

Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D

On 2021-09-15 the FDA classified a Class II recall of Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D by Angiodynamics, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2438-2021
ClassificationClass II
Statusterminated
Initiated2021-07-20
Published2021-09-15
Last updated2026-09-13 11:56 UTC
CompanyAngiodynamics
DistributionUS

Product

Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D

Reason

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.

Identifiers

code_infoSerial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2438-2021%22

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