Moderate FDA (Devices)·Z-2450-2019·Announced 2019-09-11

SonarMed AirWave Monitor Recalled Due to Potential Error Codes

SonarMed Inc is recalling 16 AirWave Monitor units because two error codes may render the devices inoperable.

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: The recall is classified as FDA Class II, and the hazard is a functional defect (inoperability) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

SonarMed Inc is recalling 16 units of the SonarMed AirWave Monitor, Model Number M0001. The recall was initiated because of the potential for the presence of two error codes which would make the monitor inoperable.

The affected units were distributed in California and Texas. The source text does not specify the exact number of units in each state or the specific facilities where they were used.

Consumers and healthcare facilities should check their inventory for the specific UDI numbers listed in the official recall notice. If a unit is affected, it should be removed from service and returned to SonarMed Inc for repair or replacement.

The recalled product

Product: SonarMed AirWave Monitor, Model Number M0001
Manufacturer: SonarMed Inc
Category: Medical Device — Monitoring Equipment
Hazard: malfunction
Affected units: 16

Distribution

Distributed in 2 states:

Same manufacturer · SonarMed Inc

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