Solero MTA Generator Requires Software Upgrade to Reduce Startup Error
Angiodynamics is servicing specific Solero MTA Generator units to upgrade the software and reduce Error 0001 during startup. Affected units are identified by serial number.
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 medical device recall with no reported injuries, illnesses, or hospitalizations. The hazard is a software error that can occur during startup; no documented adverse patient outcomes have been reported. This is a precautionary software upgrade recall.
Plain-English summary
Angiodynamics, Inc. is providing servicing for specific units of the Solero MTA Generator to upgrade the device software. This is a Class II medical device recall.
A software error, Error 0001, can occur on affected units during system start-up. The manufacturer has determined that a software upgrade is needed to help reduce the incidence of this error and ensure proper device operation.
Specific Solero MTA Generator units identified by their serial numbers require this software upgrade. The affected units have been distributed nationwide in the United States and internationally to healthcare facilities and surgical centers.
Owners and operators of Solero MTA Generators should check if their device's serial number is on the recall list. If affected, they should contact Angiodynamics, Inc. to arrange the required servicing and software upgrade.
The recalled product
- Product
- Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device
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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