BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054

    FDA Recall
    Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

    American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.

    FDA Recall
    Terminated ·American Optisurgical Inc·Product code HQC·March 24, 2009

    Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054

    FDA Recall
    Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

    COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code MWA·November 28, 2012

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Recall
    Terminated ·Philips North America Llc·Product code JAA·September 24, 2021

    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

    FDA Recall
    Terminated ·Salyer Prn Biomedical·Product code DTQ·January 31, 2013

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    FDA Recall
    Terminated ·Derma Pen, LLC·Product code PIU·February 5, 2015

    GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01. Intended for use by a qualified physician for ultrasound evaluation of Fetal?OB; abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal , PV neurological).

    FDA Recall
    Terminated ·GE Healthcare·Product code IYO·April 1, 2008

    ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code NJT·August 2, 2018

    Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·August 23, 2010

    TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·January 15, 2015

    FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·January 15, 2015

    The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code MQN·October 17, 2014

    Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·January 15, 2015

    ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·December 18, 2020

    GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·January 12, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code EZN·November 3, 2005

    Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007

    Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Onset Medical, Boston Scientific Corp., Natick, MA 01760

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code EZN·November 30, 2007