The Recall Desk

Hazard

Monitoring Error recalls

7 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2025-02-05

Of the 7 monitoring error recalls 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 hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all monitoring error recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–7 of 7

  • HighFDA (Devices)·Z-1069-2025·2025-02-05

    Bedside cardiac monitor system recalled for display distortion

    The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.

    Product
    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2023·2023-04-19

    Thermodilution Catheter May Bend During Use, Causing Monitor Errors

    Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.

    Product
    Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-2968-2018·2018-09-12

    McKesson Cardiology Hemo Software Recalled for Signal Display Issues

    McKesson Israel Ltd. is recalling McKesson Cardiology Hemo software version 13.0 because the Real Time Monitor may fail to display physiological signals under certain circumstances.

    Product
    McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytic
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0831-2015·2014-12-24

    Integra Licox Brain Tissue Oxygen Monitoring Catheters Recalled for Inaccurate Values

    Integra LifeSciences is recalling 2,506 Licox brain tissue oxygen monitoring catheters because they contain a smart card programmed with an inaccurate lkN2 value.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2015·2014-12-17

    INOmax DSIR Nitric Oxide System Recalled for Monitoring Error

    INO Therapeutics is recalling nine INOmax DSIR Nitric Oxide delivery systems because they may report lower-than-expected NO concentrations.

    Product
    INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal In
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0854-2014·2014-02-05

    GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues

    GE Healthcare is recalling CARESCAPE B650 and B850 monitors due to 25 reported safety issues involving alarms and connectivity.

    Product
    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2014·2013-12-18

    GE Healthcare Patient Monitors Recalled for Incorrect ECG Filter Settings

    GE Healthcare is recalling specific patient monitors because they may apply an incorrect ECG filter setting if impedance respiration is enabled at startup.

    Product
    HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological p
    Category
    Medical Device
    Distribution
    Distributed nationwide