The Recall Desk
ModerateFDA (Devices)·Z-2437-2021·Announced 2021-09-15

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.

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 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
Hazard
  • software-error
  • device-malfunction

Distribution

Distributed nationwide across the United States.

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