The Recall Desk

Hazard

System Failure recalls

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

What the numbers show

Total
34
Critical
0
Severe
2
Most recent
2025-07-02

Of the 34 system failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (6%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all system failure 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.

1–25 of 34

  • HighFDA (Devices)·Z-1996-2025·2025-07-02

    DxI 9000 Access Immunoassay Analyzer calibration system error recall

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to calibration issues where curves switch from passed to failed status due to system errors, potentially causing erroneous test results.

    Product
    DxI 9000 Access Immunoassay Analyzer C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0809-2025·2025-01-15

    Xhibit Telemetry Receiver may shut down, causing temporary loss of patient monitoring

    Spacelabs Healthcare's Xhibit Telemetry Receiver (Model 96280) may experience a Windows proxy issue causing the system to restart and go offline for 1-1.5 minutes, creating a temporary gap in patient monitoring.

    Product
    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1928-2024·2024-06-05

    BD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall

    CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.

    Product
    BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2024·2024-02-28

    Philips Allura Xper X-ray systems disk bay component may malfunction

    Philips has recalled certain Allura Xper interventional X-ray systems because the disk bay component may fail, potentially preventing system operation and imaging procedures.

    Product
    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2024·2023-10-18

    Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms

    Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.

    Product
    Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2024·2023-10-18

    Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift

    The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.

    Product
    Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2024·2023-10-18

    Syringe Pump Force Sensor Drift May Cause Detection Delays or False Alarms

    Smiths Medical Medfusion syringe pumps may have force sensors that drift out of calibration, causing delays in detecting line occlusions or triggering false alarms. Devices produced before April 2022 are at higher risk.

    Product
    Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0081-2024·2023-10-18

    Infusion pump component force sensor may malfunction or trigger false alarms

    Smiths Medical is recalling 118 units of Medfusion infusion pump plunger case components due to potential force sensor calibration drift. The sensor may malfunction, leading to delayed occlusion detection, false alarms, or system failure.

    Product
    Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2023·2023-08-09

    Incisive CT Computed Tomography System: Metal Mounting Box May Detach

    A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.

    Product
    Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2023·2023-02-08

    Ultrasound system hard drive defect causes device freezing and failure

    FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.

    Product
    NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2023·2022-11-23

    Philips Laser System may enter non-recoverable error state

    The Philips Laser System (REF: LAS-100) may experience system failures (Error 106 or 108) that prevent further treatment during cardiac procedures.

    Product
    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1785-2022·2022-10-05

    BD Pyxis MedBank Cabinet Software Update Prevents Drawer Access

    A software update for BD Pyxis MedBank medication dispensing cabinets contains an incompatible file that prevents Matrix drawers from opening, potentially delaying medication access in healthcare facilities.

    Product
    BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating with Windows 7. An automated dispensing cabinet intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2022·2021-12-22

    Cardiosave Hybrid IntraAortic Balloon Pump Recall Due to Fluid Ingress Risk

    Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.

    Product
    Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2021·2021-06-23

    Medtronic Custom Perfusion System Recalled for Incomplete Welds

    Specific lots of Medtronic's CB10W65R1 perfusion system tubing packs may have incomplete or insufficient welds that could compromise system integrity during cardiac surgery.

    Product
    Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2021·2021-06-23

    WorkMate Claris Cardiac Monitoring System Software Error Causes Loss of Functionality

    Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.

    Product
    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0926-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci Systems Due to Defective Capacitors

    Intuitive Surgical is recalling 52 da Vinci X surgical systems worldwide due to defective capacitors that may cause vision loss or system errors.

    Product
    da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Defective Capacitors

    Intuitive Surgical is recalling 123 da Vinci Xi surgical systems worldwide due to potentially defective capacitors that may cause vision loss or system errors.

    Product
    da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0850-2018·2018-03-14

    Philips Network Firewall Recall Due to Defective Clock Component

    Philips is recalling 332 network firewalls used with IntelliVue systems due to a defective clock component that may cause loss of connection.

    Product
    Philips Network Firewall (Cisco ASA 5506), Model # 867098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3089-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3096-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2686-2017·2017-07-26

    Siemens Artis zee X-ray System Recalled for Component Defect

    Siemens is recalling specific Artis zee angiographic x-ray systems due to a component defect that can cause failures.

    Product
    Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Ar
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2156-2017·2017-05-31

    Siemens AXIOM Sensis Diagnostic Computer Recalled for Dust-Related Failures

    Siemens Medical Solutions is recalling 4,095 AXIOM Sensis diagnostic computers because dust accumulation can cause system failures, potentially interrupting clinical treatments.

    Product
    AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2017·2017-03-29

    Merge Eye Station Import Utility Recalled for System Lockup Risk

    Merge Healthcare is recalling the Eye Station Import Utility software because system lockups may cause patient injury or delay diagnosis.

    Product
    Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2885-2016·2016-10-05

    Spacelabs Xhibit Central Station Recalled for System Lockups and Alarm Failures

    Spacelabs Healthcare is recalling Xhibit Central Stations because the telemetry system may go offline, lock up, or fail to display audio and visual alarms for asystole.

    Product
    Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2016·2016-03-02

    Siemens Mammomat Inspiration Recall for Potential System Fatal Error

    Siemens is recalling 76 Mammomat Inspiration units because a system fatal error may occur during tomosynthesis reconstruction for large breasts, causing the process to abort.

    Product
    Mammomat Inspiration with Tomosynthesis functionality
    Category
    Medical Device
    Distribution
    Distributed nationwide