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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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