BEUDAMED
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    Bone Marrow Transplantation biopsy needle

    FDA Recall
    Completed ·M.D.L. S.r.l. Via Tavani N. 1/A Delebio Italy·Product code DWO·August 5, 2021

    Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO

    FDA Enforcement
    Class II ·Completed·LEASEIR TECHNOLOGIES SLU·January 28, 2026

    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code DQK·March 16, 2022

    vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

    FDA Recall
    Completed ·Vyaire Medical·Product code LSZ·October 27, 2023

    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

    FDA Recall
    Completed ·Vyaire Medical·Product code LSZ·October 27, 2023

    Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000

    FDA Recall
    Completed ·Product code IYE·November 15, 2023

    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

    FDA Recall
    Completed ·Vyaire Medical·Product code CBK·May 5, 2023

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

    FDA Recall
    Completed ·Vyaire Medical·Product code CBK·May 5, 2023

    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

    FDA Recall
    Completed ·Fresenius Kabi USA, LLC·Product code FRN·September 16, 2022

    Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4

    FDA Recall
    Completed ·Cytrellis Biosystems, Inc.·Product code QAI·April 7, 2023

    3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000

    FDA Recall
    Completed ·Philips Ultrasound, Inc.·Product code ITX·June 30, 2023

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Recall
    Completed ·Bio-Rad Labs·Product code MVM·April 3, 2019

    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

    FDA Recall
    Completed ·CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands·Product code DQK·April 13, 2017