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.
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: 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
- Affected units
- 8
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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