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SonarMed recalls Airway Acoustic Sensors

SonarMed Inc. is recalling SonarMed Airway acoustic sensors due to a restricted inner diameter of SonarMed Airway resulting in difficulty passing a suction catheter through the sensor (2.5mm, 3.0mm, and 3.5mm).

Use of the affected SonarMed Sensors may cause serious adverse health consequences, including delays in treatment, low oxygen levels (hypoxia), air leaking into the chest cavity (pneumothorax), not enough air reaching the lungs (hypoventilation), harm to the tissues, slow heart rate (bradycardia), or even breathing problems leading to respiratory failure.

There have been 1 reported injury and no reports of death.

Who may be affected

  • Health care providers who use the SonarMed airway monitoring system to support the management of artificial airways.
  • People who receive care with the SonarMed airway monitoring system is intended for use by trained medical professionals to support the management of artificial airways.

U.S. Food and Drug Administration

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