Spacelabs Healthcare recalls
Spacelabs Healthcare appears in 47 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 47 |
|---|---|
| Published | 2012-06-27 to 2026-08-19 |
| By agency | FDA Device (47) |
| By classification | Class II (45), Class I (2) |
| By status | terminated (34), ongoing (13) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WY |
Recalls
- Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelab…
FDA Device · Class II · 2026-08-19 · Spacelabs Healthcare
Reason: Due to off-the-shelf display port component that has audio/video failures - Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product…
FDA Device · Class II · 2026-05-13 · Spacelabs Healthcare
Reason: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). - Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Device · Class II · 2026-04-15 · Spacelabs Healthcare
Reason: 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 me… - Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology In…
FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare
Reason: 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 naviga… - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare
Reason: 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 ano… - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare
Reason: 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 ano… - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare
Reason: 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 ano… - Xhibit Telemetry Receiver with Software, Model 96280
FDA Device · Class II · 2025-01-15 · Spacelabs Healthcare
Reason: 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… - Xhibit Telemetry Receiver, Model 96280, with Service Manual
FDA Device · Class II · 2025-01-15 · Spacelabs Healthcare
Reason: 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… - Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record…
FDA Device · Class II · 2024-12-25 · Spacelabs Healthcare
Reason: 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 d… - Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory elec…
FDA Device · Class II · 2024-12-25 · Spacelabs Healthcare
Reason: 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 d… - Ultraview SL (UVSL) Command Module, Model 91496
FDA Device · Class II · 2023-05-10 · Spacelabs Healthcare
Reason: 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 wit… - Xhibit Telemetry Receiver, Model: 96280
FDA Device · Class II · 2022-08-17 · Spacelabs Healthcare
Reason: 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 in… - Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and…
FDA Device · Class II · 2020-12-16 · Spacelabs Healthcare
Reason: 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… - Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neon…
FDA Device · Class II · 2020-06-10 · Spacelabs Healthcare
Reason: 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. - Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2
FDA Device · Class II · 2019-07-31 · Spacelabs Healthcare
Reason: Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. - Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999
FDA Device · Class I · 2018-08-22 · Spacelabs Healthcare
Reason: Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle. - Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection…
FDA Device · Class II · 2018-02-14 · Spacelabs Healthcare
Reason: Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. - Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia…
FDA Device · Class I · 2017-11-29 · Spacelabs Healthcare
Reason: 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 wi… - Xhibit Central Station, Model 96102
FDA Device · Class II · 2016-11-09 · Spacelabs Healthcare
Reason: The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally. - Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Ce…
FDA Device · Class II · 2016-10-05 · Spacelabs Healthcare
Reason: 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 hospita… - Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280
FDA Device · Class II · 2016-10-05 · Spacelabs Healthcare
Reason: 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 hospita… - 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B:…
FDA Device · Class II · 2016-08-10 · Spacelabs Healthcare
Reason: 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… - The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to…
FDA Device · Class II · 2016-04-27 · Spacelabs Healthcare
Reason: 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… - Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those pa…
FDA Device · Class II · 2016-03-16 · Spacelabs Healthcare
Reason: 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. - Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall…
FDA Device · Class II · 2015-11-04 · Spacelabs Healthcare
Reason: 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 w… - Spacelabs qube Compact Monitor, Model 91390
FDA Device · Class II · 2015-05-20 · Spacelabs Healthcare
Reason: 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… - Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02
FDA Device · Class II · 2015-05-13 · Spacelabs Healthcare
Reason: 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… - Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option
FDA Device · Class II · 2015-05-06 · Spacelabs Healthcare
Reason: 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 w… - Spacelabs Healthcare qube Compact Monitor, Model 91390
FDA Device · Class II · 2015-03-04 · Spacelabs Healthcare
Reason: Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following p… - Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393
FDA Device · Class II · 2015-03-04 · Spacelabs Healthcare
Reason: 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 fol… - Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms
FDA Device · Class II · 2014-10-01 · Spacelabs Healthcare
Reason: 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 discove… - ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor
FDA Device · Class II · 2014-09-10 · Spacelabs Healthcare
Reason: 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… - Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09)
FDA Device · Class II · 2014-07-23 · Spacelabs Healthcare
Reason: With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. - Spacelabs Healthcare Qube Compact Monitor, Model 91390
FDA Device · Class II · 2014-07-02 · Spacelabs Healthcare
Reason: 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 po… - Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
FDA Device · Class II · 2014-06-25 · Spacelabs Healthcare
Reason: 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… - Spacelabs Medical Ultraview SL Command Module, Model 91496
FDA Device · Class II · 2014-06-11 · Spacelabs Healthcare
Reason: A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms. - Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10
FDA Device · Class II · 2014-04-02 · Spacelabs Healthcare
Reason: 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. - ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient popu…
FDA Device · Class II · 2014-02-05 · Spacelabs Healthcare
Reason: 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 patie… - Spacelabs Healthcare qube Compact Patient Monitor, Model 91390
FDA Device · Class II · 2013-11-27 · Spacelabs Healthcare
Reason: Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component. - Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms
FDA Device · Class II · 2013-11-20 · Spacelabs Healthcare
Reason: 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. - Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03
FDA Device · Class II · 2013-01-23 · Spacelabs Healthcare
Reason: 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, M… - qube Compact Monitor (Patient Monitor) 91390
FDA Device · Class II · 2012-11-28 · Spacelabs Healthcare
Reason: 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 monit… - The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and he…
FDA Device · Class II · 2012-11-14 · Spacelabs Healthcare
Reason: Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. - Ultraview SL 91493 Integrated Module Housing
FDA Device · Class II · 2012-09-26 · Spacelabs Healthcare
Reason: 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. - Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or…
FDA Device · Class II · 2012-07-25 · Spacelabs Healthcare
Reason: 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 retu… - The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0.…
FDA Device · Class II · 2012-06-27 · Spacelabs Healthcare
Reason: 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 updat…