Tempus Pro - 92512

An issue has been identified with the Tempus Pro monitor where an error may occur during video laryngoscope use with the Tempus Pro video laryngoscope or immediately after the Tempus Pro video laryngoscope has been unplugged from the Tempus Pro monitor. If this error occurs, the user is presented with an unexpected full screen message informing the user an error has occurred, requiring shutdown and restart of the Tempus Pro monitor. This full screen message prevents the user from viewing any graphical representation of patient vital signs; however, text and numerical values are still visible on the device's display screen. If this error occurs, the pulse tone (audio) that reflects the patient's level of oxygen saturation is no longer sounded. Additionally, the user will no longer be able to visualize the airway requiring the user to either intubate the patient without video imaging or use an alternative laryngoscope not connected to the tempus pro monitor. This message cannot be cleared from the Tempus Pro monitor's screen, and most of the monitoring functions are not available, until the user initiates a complete shut down and restart of the device, which may take 60-100 seconds. The issue was identified via customer complaints. There have been no reports of patient harm.

Recall start date: August 28, 2023