The Recall Desk

Manufacturer

Spacelabs Healthcare, Llc

10 recalls in our database name Spacelabs Healthcare, Llc as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2014-04-02

Of the 10 recalls from Spacelabs Healthcare, Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

  • ModerateFDA (Devices)·Z-1273-2014·2014-04-02

    Spacelabs Recalls G2 Clinical Access Software CDs Due to Incorrect Programs

    Spacelabs Healthcare is voluntarily recalling G2 Clinical Access Software CDs because they contain incorrect programs, preventing customers from installing the software.

    Product
    Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2014·2014-02-05

    Spacelabs AriaTelemetry Transmitters Recalled for SpO2 Display Errors

    Spacelabs is recalling AriaTelemetry transmitters because they may display SpO2 values when sensors are disconnected or failed.

    Product
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2014·2013-11-27

    Spacelabs qube Patient Monitor Recalled for Power-On Failure

    Spacelabs Healthcare is recalling 54 qube Compact Patient Monitors because an incorrect microcontroller may prevent the device from powering on.

    Product
    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0188-2014·2013-11-20

    Spacelabs elance Vital Signs Monitor Recalled Due to Sensor Connection Failure

    Spacelabs Healthcare is recalling 89 elance Vital Signs Monitors because they cannot connect to Spacelabs TruLink SpO2 sensors.

    Product
    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0694-2013·2013-01-23

    Spacelabs Smart Disclosure System Recalled for Incorrect Waveform Display

    Spacelabs Healthcare is recalling the Smart Disclosure System, Model 92810, because it may display or print incorrect patient waveforms for the indicated time.

    Product
    Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0403-2013·2012-11-28

    Spacelabs Qube Compact Patient Monitor Recalled for Input Circuit Failure

    Spacelabs Healthcare is recalling Qube Compact Patient Monitors because the input circuit may fail, causing the device to shut down when batteries deplete or fail to turn on.

    Product
    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0196-2013·2012-11-14

    Spacelabs Healthcare Recalls Xprezzon Bedside Monitor Touchscreen Displays

    Spacelabs Healthcare is recalling 169 Xprezzon bedside monitor touchscreen displays because alarm lights may fail to illuminate upon installation.

    Product
    The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2012·2012-09-26

    Spacelabs Ultraview SL Integrated Module Housing Recalled for Potential Failure

    Spacelabs Healthcare is recalling Ultraview SL Integrated Module Housings because they may fail, causing patient module parameters to drop off the monitor display or preventing modules from signing on.

    Product
    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm prior
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2019-2012·2012-07-25

    Spacelabs Xprezzon Bedside Monitor Recalled for Display Disconnection

    Spacelabs Healthcare is recalling 21 Xprezzon Bedside Monitors because specific key presses can cause patient parameters to disappear from the display.

    Product
    Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1831-2012·2012-06-27

    Spacelabs Healthcare Recalls Pathfinder SL Holter Analyzer Software

    Spacelabs Healthcare is recalling Pathfinder SL software due to crashes and incorrect QTc values. The software is used to analyze Holter monitor data.

    Product
    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used t
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Spacelabs Healthcare

American medical equipment manufacturer

Country
United States
Founded
1958
Parent company
OSI Systems

Official website

Source: Wikidata (Q7572694), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.