BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V

    FDA Recall
    Terminated ·Product code GAM·June 6, 2007

    VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code JJY·July 10, 2017

    VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    FDA Recall
    Terminated ·Alivecor SFO·Product code DXH·January 9, 2015

    Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.

    FDA Recall
    Terminated ·Smith & Nephew, Inc Endoscopy Division·Product code FFS·April 9, 2007

    Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code JFS·September 2, 2016

    Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages

    FDA Recall
    Terminated ·Cook Inc.·Product code FFS·May 3, 2017

    Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.

    FDA Recall
    Terminated ·Medela Inc·Product code HFS·May 18, 2011

    Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code JFS·September 2, 2016

    The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor. The instrument management subsystem is capable of connectivity with clinical analyzers, a Laboratory Information Systems (LIS), barcode label printers and other third party devices. The TCAutomation is a pre-analytical and post-analytical sample management system. The configuration file enables operational support of the site specific layout and instrument selection. The VITROS 5, 1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric Immunoassay methods.)

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·January 27, 2011

    Discovery IGS 740 Interventional Fluoroscopic X-ray Systems

    FDA Recall
    Terminated ·GE Medical Systems, SCS·Product code OWB·March 29, 2018

    Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

    FDA Recall
    Terminated ·GE Medical Systems, SCS·Product code OWB·March 29, 2018

    Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems

    FDA Recall
    Terminated ·GE Medical Systems, SCS·Product code OWB·March 29, 2018

    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

    FDA Recall
    Terminated ·MEDTECH SAS Parc Euromedecine Batiment·Product code HAW·May 8, 2018

    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.

    FDA Recall
    Terminated ·SEPPIM SAS ZONE INDUSTRIELLE SEES France·Product code CJY·September 4, 2013

    CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.

    FDA Recall
    Terminated ·Trophy Sas 4 Rue Pelloutier Croissy Beaubourg France·Product code EAP·September 18, 2012