The Recall Desk

Hazard

Equipment Malfunction recalls

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

What the numbers show

Total
147
Critical
1
Severe
11
Most recent
2026-09-09

Of the 147 equipment malfunction recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (7%) 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 equipment malfunction 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.

101–125 of 147

  • HighFDA (Devices)·Z-2472-2021·2021-09-22

    Alinity ci-series System Control Module Software Performance Issues

    Abbott's Alinity ci-series analyzers with software version 3.2.3 and earlier have multiple issues that could display expired reagents as valid, fail to alert operators to errors, and produce incorrect test results.

    Product
    Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2417-2021·2021-09-15

    Philips MRI System Tabletop May Not Fully Move in Manual Mode

    Philips Ingenia 3.0T-a MRI systems have an issue where the tabletop may not completely move in or out during manual operation. This could delay patient evacuation from the scanner bore and postpone medical treatment.

    Product
    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2421-2021·2021-09-15

    MRI Tabletop Movement Failure May Delay Patient Evacuation and Treatment

    Philips MRI systems may fail to move the examination tabletop in manual mode, potentially delaying patient evacuation and medical treatment.

    Product
    SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or ext
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2422-2021·2021-09-15

    Philips Ingenia Ambition X MRI System Tabletop May Fail to Retract

    Philips Ingenia Ambition X MRI systems may have tabletops that fail to move completely in manual mode, potentially delaying patient evacuation from the scanner and treatment. The issue affects 147 units distributed worldwide.

    Product
    Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2413-2021·2021-09-15

    MRI device tabletop may fail to move completely in manual mode

    Philips Ingenia MRI tabletops may fail to move completely in manual mode, potentially delaying patient evacuation. The recall affects 144 units worldwide.

    Product
    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 7813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2021·2021-09-15

    MRI Magnetic Resonance System Tabletop May Fail to Move in Manual Mode

    Philips Ingenia Elition S-a MRI systems may have tabletop movement failure in manual mode, potentially delaying patient evacuation from the scanner bore and treatment. This affects 64 units distributed worldwide.

    Product
    Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2416-2021·2021-09-15

    Ingenia Ambition S-a MRI System tabletop may not move in manual mode

    The Philips Ingenia Ambition S-a MRI system may not fully move its patient tabletop in or out of the bore during manual mode operation, potentially delaying patient evacuation and treatment.

    Product
    Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2415-2021·2021-09-15

    MRI System Tabletop May Fail to Move, Delaying Patient Evacuation

    Philips MRI systems (Model 781260) may have a tabletop malfunction in manual mode that prevents complete movement, potentially delaying patient evacuation and treatment.

    Product
    SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremitie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Insufficient Welds

    Medtronic Perfusion System tubing packs are recalled due to manufacturing defects involving insufficient or incomplete welds in the CB10W63R1 lot. Affected devices may malfunction during use.

    Product
    Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2021·2021-02-24

    Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to reports of kinked access lines observed during treatment.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1119-2021·2021-02-24

    Baxter Gambro Cartridge Single Needle Conversion Kit Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Single Needle Conversion Kits due to reports of kinked access lines during hemodialysis treatments.

    Product
    Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2356-2020·2020-06-17

    BD FACS Sample Prep Assistant II Recalled for Probe Wear Issues

    Becton, Dickinson and Company is recalling 95 units of the BD FACS Sample Prep Assistant II because probes may wear prematurely, causing sample dispensing failures.

    Product
    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphoc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2031-2019·2019-07-31

    Siemens Artis zee Biplane Recalled for Generator Power Supply Tolerance Issue

    Siemens is recalling 268 Artis zee biplanes because a power supply tolerance issue may cause generator failure, preventing X-ray production during procedures.

    Product
    Artis zee biplane, Model Number 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2019·2019-06-12

    Accuray Recalls CyberKnife M6 Systems Due to Collimator Housing Drop Risk

    Accuray is recalling 68 CyberKnife M6 systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.

    Product
    CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: Cyb
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1291-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 62 VITROS XT 7600 Integrated Systems worldwide because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2591-2018·2018-08-08

    ELITech Recalls ENVOY 500 ISE Calibrator Kits Due to Calibration Failures

    ELITech Clinical Systems is recalling ENVOY 500 ISE Calibrator Kits because some vials cause calibration errors, delaying patient results.

    Product
    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0403-2018·2018-01-31

    Philips Brilliance iCT CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling 559 Brilliance iCT CT systems due to software issues affecting scan functions and safety features.

    Product
    Brilliance iCT - Model 728306 Computed Tomography X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2018·2018-01-31

    Philips Brilliance iCT CT Systems Recalled for Software Defects

    Philips is recalling Brilliance iCT CT systems due to software issues affecting scan functions and safety features.

    Product
    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2017·2017-07-05

    Shimadzu Ceiling X-ray Tube Support Recalled for Potential Cracks

    Shimadzu Medical Systems is recalling ceiling-type X-ray tube supports because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2017·2017-04-12

    Philips BrightView XCT Gamma Cameras Recalled for Brake Hub Assembly Error

    Philips is recalling 90 BrightView XCT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0056-2017·2016-10-19

    Natus Medical Recalls Medix NatalCare LX Incubators Due to Wheel Defect

    Natus Medical is recalling 104 Medix NatalCare LX Intensive Care Incubators because a defective base weld may cause wheels to bend out of alignment.

    Product
    The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2385-2016·2016-08-17

    Philips Ingenuity CT Software Recall for Performance Issues

    Philips Medical Systems is recalling 205 Ingenuity CT units due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.

    Product
    Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2395-2016·2016-08-17

    Siemens Medical Solutions Recalls Artis Q and Q.Zen Angiography Systems

    Siemens Medical Solutions is recalling Artis Q and Q.Zen angiography systems because biomass in the cooling system may damage the pump.

    Product
    ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includi
    Category
    Medical Device
    Distribution
    Distributed nationwide