The Recall Desk
ModerateFDA (Devices)·Z-2436-2021·Announced 2021-09-15

Solero MTA Generator requires software upgrade for startup error

Angiodynamics is recalling specific refurbished Solero MTA Generators due to Error 0001, which occurs during system startup. A software upgrade is required to reduce the error's frequency.

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: FDA Class II device recall with no reported illnesses or injuries and no explicit harm described. The recall is precautionary, addressed through software upgrade to reduce the incidence of a software error that occurs during system startup.

Plain-English summary

Angiodynamics, Inc. is recalling specific refurbished Solero MTA Generators due to a software error that occurs during system startup. The recall affects 16 units distributed in the United States and 2 units distributed internationally. The affected devices are identified by specific serial numbers.

The manufacturer recommends a software upgrade to reduce the occurrence of Error 0001, which can appear during system startup. The source documentation provides no information regarding the consequences of this error, any reported malfunctions, or any reported injuries or adverse events.

Owners of affected Solero MTA Generators should verify their device's serial number against the list provided by the FDA. Customers with affected units should contact Angiodynamics, Inc. to arrange the required software upgrade.

The recalled product

Product
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Manufacturer
Angiodynamics, Inc.
Category
Medical Device
Hazard
  • software-error

Distribution

Distributed nationwide across the United States.

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