Hazard

Equipment Malfunction recalls

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

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.

26–50 of 108

HighFDA (Devices)·Z-0456-2025·2024-11-20
MEERA CL Mobile Operating Table Control Malfunction Recall
The MEERA CL mobile operating table may experience error code 50037 that stops table movement during use, causing surgical procedure delays. Getinge recalled 342 units distributed worldwide.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0458-2025·2024-11-20
MEERA CL operating table stops responding during surgery when IR-Hand Control errors occur
The MEERA CL surgical operating table may fail to respond when error code 50037 occurs on its IR-Hand Control, causing the table to stop moving during procedures and resulting in procedural delays.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2025·2024-10-30
Shimadzu Trinias Unity Catheterization Table Movement Control Defect
Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.
Product
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3205-2024·2024-10-02
MRI diagnostic device screws may loosen and block tabletop
Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.
Product
SmartPath to Ingenia Elition X - 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: 782118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3198-2024·2024-10-02
Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
Product
Ingenia Ambition X - 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: 782109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3204-2024·2024-10-02
MRI Diagnostic Device Loose Screws May Block Patient Tabletop
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
Product
SmartPath to dStream for XR and 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: 1) 782113; 2) 781270; 3) 782129
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3193-2024·2024-10-02
MRI Diagnostic Device Recalls Due to Loose Screw Assembly Risk
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Product
Evolution Upgrade 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: (1) 782117 (2) 782143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3199-2024·2024-10-02
MRI Diagnostic Device Recalled for Loose Assembly Screws Blocking Equipment
Philips Ingenia Elition S MRI machines (10 units) are recalled because assembly screws may come loose and interfere with the horizontal tabletop, potentially delaying diagnosis and causing patient anxiety.
Product
Ingenia Elition S -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: 1) 782150 2) 782106
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3180-2024·2024-09-25
Beckman Coulter Analyzer Recalled for Pneumatic Tubing Defects
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing in the reagent storage module, which can cause air leaks and compressor failures, potentially leading to test errors and delayed results.
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3106-2024·2024-09-18
Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss
Medline Industries is recalling anesthesia circuit kits due to reported adverse events indicating potential loss of suction during intermittent use. Approximately 29,585 units distributed in the US, Canada, and Panama are affected.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C; c) ANESTHESIA CIRCUIT ADULT, Pack Number DYNJAA0378A; d) ADULT ANESTHESIA CIRC LAGUNA, Pa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2951-2024·2024-09-11
Anesthesia System Vaporizer Adapter Recalled for Potential Anesthetic Overdose
Mindray's Isoflurane E_Vap adapter for the A9 Anesthesia System is recalled due to a seal defect that may cause higher-than-intended anesthetic concentration delivery. Twenty-four units were distributed to eight U.S. states and Canada.
Product
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2980-2024·2024-09-11
Beckman Power Express Centrifuge Sample Holder May Detach During Operation
An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.
Product
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2720-2024·2024-09-04
Medical Device: Ion Endoluminal System Recalled for Instrument Arm Screw Failure
Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.
Product
Ion Endoluminal System, REF: 380748-65
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2716-2024·2024-08-28
Philips Allura Xper Interventional Fluoroscopy Systems Recalled for Incorrect Bolt
Philips Allura Xper systems contain an incorrect half-threaded bolt in LTE kits instead of the required full-threaded bolt. Six units distributed worldwide have been affected.
Product
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2341-2024·2024-07-17
Blood Pump Rotor Guide Sheaves May Loosen in Home Hemodialysis System
Fresenius is recalling Blood Pump Rotor components in 2008K@HOME hemodialysis systems due to reports of loose or dislodged guide sheaves that could affect pump function. Affected patients should contact their clinic to verify involvement.
Product
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2273-2024·2024-07-17
ALPHAMAXX Mobile Operating Table Charger Defect Poses Equipment Failure Risk
Getinge has recalled 7 ALPHAMAXX mobile operating tables due to a defective charger unit that may not charge properly, risking equipment operational failure during use.
Product
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2242-2024·2024-07-10
ARTIS Angiography Systems Recalled for Potential Radiation Overdose
Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.
Product
ARTIS 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-2237-2024·2024-07-10
Beckman Coulter DxI 9000 Analyzer Tubing Malfunction Causes Test Errors
Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human bod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2217-2024·2024-07-03
NovaGuide 2 Ultrasound System Recall Due to Grounding Cable Disconnection Risk
NovaGuide 2 Traditional Ultrasound systems may have grounding cables that can be inadvertently disconnected during use, creating risk of electrical shock and equipment malfunction. Twenty-eight systems have been distributed nationwide.
Product
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2216-2024·2024-07-03
NovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk
FDA is recalling 45 NovaGuide 2 Intelligent Ultrasound systems due to a defective grounding cable that could become disconnected and cause electrical shock, electrical interference, or equipment malfunction.
Product
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1892-2024·2024-06-05
FDA Recalls Mirion Captus 4000e Thyroid Uptake System for Collimator Detachment
The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.
Product
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1598-2024·2024-04-24
Siemens Artis X-ray systems cooling malfunction may halt procedures
Siemens Artis interventional X-ray systems may fail to cool the X-ray tube adequately, causing system shutdown and potentially requiring cancellation of clinical imaging procedures. The recall affects 583 units distributed nationwide.
Product
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q bipl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1538-2024·2024-04-24
Masimo Rad-G Pulse Oximeter automatic power cycling may cause monitoring loss
Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.
Product
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2024·2024-03-13
VITROS XT7600 System Aspiration Risk During Sample Processing
Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.
Product
VITROS XT7600 Integrated System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1214-2024·2024-03-06
Colonoscope Model PCF-Q180AL Recalled Due to Missing Protective Adhesive
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
Product
Colonoscope, Model Number PCF-Q180AL.
Category
Medical Device
Distribution
Distributed nationwide