The Recall Desk

Hazard

Hardware Failure recalls

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

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2026-01-08

Of the 10 hardware 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 0 (0%) 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 hardware 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.

1–10 of 10

  • HighFDA (Devices)·Z-1663-2025·2025-04-30

    Skytron Freedom Monitor Mount Hardware Recall for Inadequate Thread Engagement

    The mounting hardware supplied with the Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount does not provide adequate thread engagement to support the weight of the frame and monitor, creating a risk of hardware failure and separation.

    Product
    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3195-2024·2024-10-02

    Philips Ingenia 3.0T MRI Scanner Tabletop Blockage Risk

    Philips is recalling 33 Ingenia 3.0T MRI scanners whose Integrated Radio Frequency Carrier assembly screws may come loose and block the horizontal tabletop, potentially causing diagnostic delays.

    Product
    Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1049-2023·2023-02-08

    Lucid TCD 2.0 Transcranial Ultrasound System Recalled for Hard Drive Failure

    The Lucid TCD 2.0 System has a faulty hard drive that causes the device to freeze and reboot. Eventually, the system becomes completely inoperable.

    Product
    Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1351-2022·2022-07-20

    Philips LAS-100 Laser System may not operate due to detected hardware failure

    Spectranetics' Philips LAS-100 Laser System (105 units) may fail to start if the device detects an inoperable hardware component during power-up, requiring manual error code clearing before operation.

    Product
    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0851-2022·2022-04-06

    Hanger-Bar 2P Medical Device Recalled for Loosening Set Screw

    Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect allowing the set screw to loosen, creating a fall hazard.

    Product
    Hanger-Bar 2P 45cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0762-2020·2020-01-08

    Deerfield iMRX MRI and Angiography System Recalled for Hardware Error

    Deerfield Imaging is recalling six iMRX MRI and Angiography Systems due to a potential hardware error in the generator A100 power supply that may prevent X-ray operation.

    Product
    iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRI
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1479-2017·2017-03-22

    Philips BrightView XCT Nuclear Imaging Systems Recalled for Four Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView XCT nuclear imaging systems worldwide due to four hardware issues, including motion controller failures and door interlock problems.

    Product
    882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2016·2015-11-18

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Hardware Defects

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the CO2 inlet port can become inaccessible or the handle can separate from the housing.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1567-2013·2013-07-03

    GE Healthcare Recalls CARESCAPE Monitor B850 for Software and Hardware Issues

    GE Healthcare is recalling 12,779 CARESCAPE Monitor B850 units due to four potential issues, including uDOM failure, unstable USB communication, remote printing errors, and reboots caused by an X server freeze.

    Product
    CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The sy
    Category
    Medical Device
    Distribution
    Distributed nationwide