SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Reported: January 26, 2022 Initiated: December 22, 2021 #Z-0514-2022
Product Description
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Reason for Recall
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 66 devices
- Distribution
- The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT). Recalled by Covidien, LP. Units affected: 66 devices.
Why was this product recalled? ▼
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0514-2022.
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