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  • Device 1608
  • Manufacturer 1608
  • Event 1666
  • Implant 0
unkown device
  • Model / Serial
    6802413, software version 3.1
  • Product Description
    This equipment is indicated for use in in vitro diagnostics in quantitative, semiquantitative and qualitative in vitro measurement of different analytes of clinical interest.
  • Manufacturer
    Orthoclinical Diagnostics, Inc.
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    BRILLIANCE 64 INGENUITY CORE, software version 4.1.6.XX030, serial 30034.
  • Product Description
    Acquisition of radiological diagnostic images using X-ray computed tomography to help physicians in the diagnosis and treatment of diseases by providing images.
  • Manufacturer
    Philips And Neusoft Medical System Co Ltd || Philips Medical System Technologies Ltd. || Dunlee División Of Philips Medical Systems (Cleveland) Inc || Philips Healthcare (Suzhou) Co., Ltd || Philips Medical Systems (Cleveland) Inc.
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    AFFINITY models P3700B, P3700C, P3700D and P3700E, manufactured between October 2006 and June 2014.
  • Product Description
    AFFINITY ™ FOUR obstetric beds are intended to be used as delivery cares for pregnant women with LDR (dilatation, delivery and recovery) or LDRP (dilation, delivery, recovery and postpartum). The hospital systems VERSACA RE ™ and TOTA LCA RE ™ s systems offer patient support perfectly adapted to hospital environments. Care units and intensive surveillance, medical-surgical care, post-anesthesia care unit and deurgery rooms, among others, can be used. The P ROGRESSA ™ bed is designed for the prevention or treatment of pulmonary complications or other associated complications with immobility; for the treatment or prevention of pressure ulcers; or for any other purpose where medical benefits can be obtained from continuous lateral rotation therapy or dermal / percussion therapy.
  • Manufacturer
    Hill Rom Inc
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    ACUITY CENTRAL, MICROPAQ, MOBILE ACUITY LT, PROPAQ CS, COMMUNICATION SERVER (WACS), PROPAQ || LT and 1500
  • Product Description
    Electronic device that captures and amplifies the electrical activity of the heart through electrodes placed in the 4 extremities and in 6 positions in the chest, measures the average arterial pressure, the pulse, the oxygen saturation and the temperature.
  • Manufacturer
    Welch Allyn Protocol Inc. || Welch Allyn Inc
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    HeartStart: FRx, Home, OnSite
  • Product Description
    Indicated for cardiac resuscitation and patient monitoring.
  • Manufacturer
    Philips Medical Systems || Philips Goldway(Shenzhen) Industrial Inc
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    TRILOGY 100 and TRILOGY 200, with software versions 13.2.04, 13.2.05, 14.0.00 or 14.1.01
  • Product Description
    This unit can facilitate non-invasive or invasive ventilation. It can be used to provide patients with total ventilation therapy as they progress from a non-invasive to invasive mode.
  • Manufacturer
    Respironics Inc (Sleep Therapy)
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    Definition AS and Definition FLASH
  • Product Description
    Equipment for the production of cross-sectional images of the body by means of computer reconstruction of the X-ray transmission.
  • Manufacturer
    Siemens Shanghai Medical Equipment Ltd. || Siemens Healthcare Gmbh || Siemens A.G.
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    Product code: 1450261. Affected gene: GEN 29
  • Product Description
    REAGENTS, CONTROLS AND CALIBRATORS OF THE VITROS SYSTEM FOR THE DETERMINATION OF CHEMICAL ANALYZES FROM HUMAN SAMPLES.
  • Manufacturer
    ORTHO CLINICAL DIAGNOSTICS, INC. || Importer: JOHNSON & JOHNSON DE COLOMBIA S.A.
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    6802413, software version 3.1 and earlier
  • Product Description
    This equipment is indicated for use in in vitro diagnostics in quantitative, semiquantitative and qualitative in vitro measurement of different analytes of clinical interest.
  • Manufacturer
    Orthoclinical Diagnostics, Inc.
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    LIFEPAK 20E
  • Product Classification
    Cardiovascular Devices
  • Product Description
    This equipment is indicated to be used in the patient in cardiopulmonary arrest. The patient must be unconscious, without spontaneous breathing, without signs of circulation (no pulse). It can be used additionally as a cardioverter / defibrillator according to medical criteria depending on the cardiac arrhythmia that the patient presents.
  • Manufacturer
    Physio Control , Inc
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    LIFEPAK 15
  • Product Description
    It provides stimulation to the heart for the automatic treatment of ventricular arrhythmias that endanger the life of the patient and when they exhibit symptoms of sudden parocardia.
  • Manufacturer
    Physio Control, Inc
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    620-040-600, 620-040-601, 620-040-602, 620-040-604, 620-040-610, 620-040-611, 620-040-613, 620-040-614, specific serials .
  • Product Description
    This equipment is indicated to distend or expand cavities by insufflating CO2 during diagnostic laparoscopy and / or therapy in order to increase visibility during these procedures.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    SCORPIO instrument reference Patella Assembly, specific lots.
  • Product Description
    This system allows the total or partial reconstruction of the knee.
  • Manufacturer
    Stryker Ireland Limited || Howmedica Osteonics Crop, Ahora Conocido Como Stryker || Orthopedics || Lisi Medical Orthopaedics
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    Trident impactors, references Trident Universal Impactor / 2101-0200, specific lots.
  • Product Description
    This system allows the total or partial reconstruction of the hip.
  • Manufacturer
    Stryker Ireland Limited || Howmedica Osteonics Crop, Ahora Conocido Como Stryker || Orthopedics || Lisi Medical Orthopaedics
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    Trident impactors, references Constrained Liner Impactor Tips, all lots since 2012.
  • Product Description
    This system allows the total or partial reconstruction of the hip.
  • Manufacturer
    Stryker Ireland Limited || Howmedica Osteonics Crop, Ahora Conocido Como Stryker || Orthopedics || Lisi Medical Orthopaedics
  • 2 Events
    • Safety Alert for unkown device
    • Safety Alert for unkown device
unkown device
  • Model / Serial
  • Product Description
    REAGENTS EMPLOYED FOR THE QUANTITATIVE DETERMINATION OF THE HORMONEAPARATIROIDEA INTACT (iPTH) IN SERUM AND HUMAN PLASMA.
  • Manufacturer
    ORTHO CLINICAL DIAGNOSTICS, INC. || Imported by: JOHNSON&JOHNSON DE || COLOMBIA.
  • 5 Events
    • Safety Alert for unkown device
    • Safety Alert for unkown device
    • Safety Alert for unkown device
    • Safety Alert for unkown device
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    Controls reference: 6800598, lots 0860, 0870, 0880, 0890, || 0908
  • Product Description
    QUALITATIVE DETECTION OF ANTIBODIES AGAINST THE SURFACE ANTIGEN OF HEPATITIS B (HBsAg) IN THE HUMAN SERUM AND PLASMA.
  • Manufacturer
    ORTHO CLINICAL DIAGNOSTICS || Importer: JOHNSON & JOHNSON DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    VITROS 250 and VITROS 350
  • Product Description
    The product is indicated for the analysis of in vitro tests.
  • Manufacturer
    Ortho Clinical Diagnostics Inc.
  • 1 Event
    • Safety Alert for unkown device
unkown device
  • Model / Serial
    8132086 and 6802153, specific serials.
  • Product Description
    The product is indicated for the analysis of in vitro tests.
  • Manufacturer
    Ortho Clinical Diagnostics Inc.
  • 1 Event
    • Safety Alert for unkown device
1 FS calibrator
  • Model / Serial
  • Product Description
    FOR IN-VITRO ANALYTIC DIAGNOSIS.
  • Manufacturer
    ORTHO CLINICAL DIAGNOSTICS, INC. || Imported by: JOHNSON&JOHNSON DE
  • 1 Event
    • Safety Alert for 1 FS calibrator
3 gallergy specific IGE universal kit
  • Model / Serial
  • Manufacturer
    manufacturer #121
  • 1 Event
    • Safety Alert for 3 gallergy specific IGE universal kit
8-channel DBS Electrodes Kit Infinity
  • Model / Serial
    6172ANS
  • Manufacturer
    N/A
  • 1 Event
    • Safety Alert for 8-channel DBS Electrodes Kit Infinity
AAA Endovascular System and AFX Introducer System
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    N/A
  • 1 Event
    • Safety Alert for AAA Endovascular System and AFX Introducer System
Abbott Realtime Hbv Control Kit
  • Model / Serial
  • Manufacturer
    manufacturer #121
  • 1 Event
    • Safety Alert for Abbott Realtime Hbv Control Kit
ABBOTT real time HIV-1 amplification kit
  • Model / Serial
  • Product Description
    AND IN VITRO AMPLIFICATION ASSAY FOR THE QUALITATIVE DETECTION OF NUCLEIC ACIDS DELVIRUS OF HUMAN IMMUNODEFICIENCY TYPE 1
  • Manufacturer
    manufacturer #121
  • 1 Event
    • Safety Alert for ABBOTT real time HIV-1 amplification kit
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Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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