Solero Generator PG requires software service for startup error
Angiodynamics is recalling 65 Solero Generator PG devices due to software Error 0001 that can occur during system startup. A software upgrade is required to reduce the incidence of this error.
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 recall with no reported illnesses, injuries, or adverse events. The hazard is a software error during system startup with no documented patient harm.
Plain-English summary
Angiodynamics, Inc. is recalling 65 Solero Generator PG devices (Item No. H78712740000, Catalog No. 12740000) identified by specific serial numbers. The manufacturer has determined that Error 0001 can occur during system start-up on affected units.
To address this issue, Angiodynamics is providing a software upgrade to help reduce the incidence of Error 0001. The affected devices were distributed domestically throughout the United States and internationally worldwide.
Owners and operators of devices with the affected serial numbers should contact Angiodynamics to arrange the required software servicing. The complete list of affected serial numbers is available in the official FDA recall notice.
The recalled product
- Product
- Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 65
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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