RegWardenFDA facility compliance records
Facility

Spacelabs Healthcare Inc.

42 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 6 recalls; 2013: 3 recalls; 2014: 7 recalls; 2015: 5 recalls; 2016: 5 recalls; 2017: 1 recalls, 1 inspections; 2018: 2 recalls, 1 inspections; 2019: 2 recalls; 2020: 1 recalls; 2022: 1 recalls, 1 inspections; 2023: 1 recalls; 2024: 3 recalls; 2025: 2 recalls; 2026: 3 recalls6’123’137’145’155’162’173’182’191’20’212’221’233’242’253’26
  • Recalls (42)
  • Inspections (3)

Devices registered here (1)

Recalls & enforcement

20263 records
  • Class IIOngoing2026-06-04
    Due to off-the-shelf display port component that has audio/video failures
  • Class IIOngoing2026-03-26
    Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
  • Class IIOngoing2026-02-27
    Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in ina…
20252 records
  • Class IIOngoing2025-09-16
    Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be…
  • Class IIOngoing2025-09-05
    Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
20243 records
  • Class IIOngoing2024-11-25
    Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not d…
  • Class IIOngoing2024-11-25
    Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not d…
  • Class IIOngoing2024-11-25
    Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
20231 record
  • Class IIOngoing2023-04-12
    Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially …
20221 record
  • Class IIOngoing2022-05-31
    Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as speci…
20201 record
  • Class IITerminated2020-11-06
    During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Test…
20192 records
  • Class IITerminated2019-08-30
    The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
  • Class IITerminated2019-01-28
    Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
20182 records
  • Class ITerminated2018-07-11
    Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
  • Class IITerminated2018-01-17
    Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
20171 record
  • Class ITerminated2017-10-11
    Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
20165 records
  • Class IITerminated2016-10-18
    The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
  • Class IITerminated2016-08-25
    The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
  • Class IITerminated2016-07-01
    The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.
  • Class IITerminated2016-03-28
    Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Offline error message for all patients bei…
  • Class IITerminated2016-02-26
    The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.
20155 records
  • Class IITerminated2015-09-03
    When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.
  • Class IITerminated2015-05-08
    The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).
  • Class IITerminated2015-04-21
    Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may …
  • Class IITerminated2015-04-17
    Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms w…
  • Class IITerminated2015-01-28
    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.
20147 records
  • Class IITerminated2014-08-26
    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…
  • Class IITerminated2014-07-02
    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…
  • Class IITerminated2014-06-18
    With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
  • Class IITerminated2014-06-06
    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 al…
  • Class IITerminated2014-05-09
    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.
  • Class IITerminated2014-05-08
    A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
  • Class IITerminated2014-02-14
    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.
20133 records
  • Class IITerminated2013-12-19
    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.
  • Class IITerminated2013-10-17
    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.
  • Class IITerminated2013-10-17
    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.
20126 records
  • Class IITerminated2012-12-05
    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.
  • Class IITerminated2012-10-19
    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 …
  • Class IITerminated2012-10-05
    Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.
  • Class IITerminated2012-08-27
    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.
  • Class IITerminated2012-06-12
    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.
  • Class IITerminated2012-05-11
    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.

FDA inspections (3)

  • VAI2022-09-15
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2018-06-01
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2017-03-09
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Spacelabs Healthcare Inc. (FEI 3010157426) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010157426-spacelabs-healthcare-inc/

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