BEUDAMED
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    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Recall
    Completed ·Philips North America Llc·Product code JAK·March 29, 2022

    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    FDA Enforcement
    Class II ·Completed·SynCardia Systems LLC·November 1, 2023

    Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

    FDA Enforcement
    Class II ·Completed·ESAOTE S.P.A.·March 11, 2026

    Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.

    FDA Enforcement
    Class II ·Completed·Abbott Laboratories, Inc·November 29, 2017

    Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

    FDA Enforcement
    Class II ·Completed·Fukuda Denshi Co., Ltd.·December 13, 2017

    Revolution CT

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·July 14, 2021

    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

    FDA Enforcement
    Class II ·Completed·Beckman Coulter, Inc.·July 23, 2025

    ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.

    FDA Enforcement
    Class II ·Completed·Abbott Laboratories, Inc·November 29, 2017

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    FDA Enforcement
    Class II ·Completed·Murata Vios, Inc.·January 22, 2025

    microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059

    FDA Enforcement
    Class II ·Completed·Landauer·March 27, 2024

    Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

    FDA Enforcement
    Class II ·Completed·Trumpf Medical Systems, Inc.·January 6, 2016

    Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001

    FDA Enforcement
    Class II ·Completed·Align Technology Inc·February 1, 2023

    COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.

    FDA Enforcement
    Class II ·Completed·Avanos Medical, Inc.·September 27, 2023

    The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

    FDA Enforcement
    Class II ·Completed·QUANTUM SURGICAL SAS·October 16, 2024

    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

    FDA Enforcement
    Class II ·Completed·Vyaire Medical·June 21, 2023

    bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator

    FDA Enforcement
    Class II ·Completed·Vyaire Medical·June 21, 2023

    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Enforcement
    Class II ·Completed·Exactech, Inc.·July 7, 2021

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Enforcement
    Class II ·Completed·Beckman Coulter Mishima K.K.·June 11, 2025

    ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease

    FDA Recall
    Completed ·Advanced Research Medical, LLC·Product code MAX·March 14, 2023