SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Check against the official notice below — it lists the full affected range.
Covidien, LP is recalling the SonarMed AirWave Monitor Kit, a device used with endotracheal tubes that monitors patient airway status. The recalled devices experienced two defects prior to patient use: the alarm speaker failed to produce sound when powered on, and the device falsely detected sensor cable disconnections and reconnections during setup. When the monitor detected these false disconnections, it would stop monitoring the patient and switch to a calibration screen without triggering an audible alarm, creating a risk that critical patient monitoring could be interrupted without alerting clinical staff.
A total of 66 affected devices were distributed across nine states: California, Colorado, Florida, Illinois, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The devices can be identified by the UDI-Device Identifier (GTIN/UPN) 00851334007001 and specific serial numbers ranging from AW0501 through AW0571. The recall source does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX. Quantity: 66 devices Lot/code info: UDI-Device Identifier (GTIN/UPN): 00851334007001; Serial Numbers: AW0501 AW0519 AW0537 AW0556 AW0502 AW0520 AW0540 AW0557 AW0503 AW0521 AW0541 AW0558 AW0504 AW0522 AW0542 AW0559 AW0505 AW0524 AW0543 AW0560 AW0506 AW0525 AW0544 AW0561 AW0507 AW0526 AW0545 AW0562 AW0508 AW0527 AW0546 AW0563 AW0509 AW0528 AW0548 AW0564 AW0510 AW0529 AW0549 AW0565 AW0511 AW0530 AW0550 AW0566 AW0512 AW0531 AW0551 AW0567 AW0513 AW0532 AW0552 AW0568 AW0514 AW0533 AW0553 AW0569 AW0515 AW0536 AW0554 AW0570 AW0516 AW0538 AW0555 AW0571 AW0517 AW0539
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.