The Recall Desk
ModerateFDA (Devices)·Z-2438-2021·Announced 2021-09-15

Solero MTA Generator refurbished units require software servicing

Eight refurbished Solero MTA Generator units require software upgrades to reduce startup errors occurring in specific serial numbers.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for a software error in a medical device. No illnesses, injuries, or deaths have been reported. The manufacturer is proactively providing a software upgrade to reduce the incidence of an operational error.

Plain-English summary

Angiodynamics, Inc. is providing software upgrades for eight refurbished Solero MTA Generator units (Item No. H78712740000D0, Catalog No. 12740000D). The upgrade is required to help reduce the incidence of Error 0001, which can occur during system start-up.

The affected serial numbers are: QBY0002816, QBY0002817, QBY0002348, QBY0002308, QBY0002311, QBY0002711, QBY0002741, and QBY0002858. These units have been distributed nationwide in the United States and worldwide.

Healthcare facilities and providers who operate Solero MTA Generator units with the affected serial numbers should contact Angiodynamics, Inc. to arrange for the required software upgrade.

The recalled product

Product
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Manufacturer
Angiodynamics, Inc.
Category
Medical Device
Hazard
  • software-error

Distribution

Distributed nationwide across the United States.

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