Spacelabs Healthcare Recalls

Hazard: Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset.

Hazard: The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).

Hazard: The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.

Hazard: With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

Hazard: Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.

Hazard: Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.

Hazard: A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.

Hazard: Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access.

Hazard: The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions.

Hazard: Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.

Hazard: Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.

Hazard: Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.

Hazard: Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short.

Hazard: Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.

Hazard: There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.

Hazard: There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor.

Hazard: The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.