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.
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 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
- software-malfunction
Distribution
Distributed nationwide across the United States.
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