BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)

    FDA Recall
    Terminated ·Olympus America Inc. Two·Product code LMB·August 19, 2003

    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code KNS·November 10, 2009

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEB·June 23, 2016

    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code GEI·September 27, 2013

    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 5830 El Camino Real·Product code NKB·May 5, 2017

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 5830 El Camino Real·Product code NKB·October 5, 2016

    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code LWP·April 29, 2014

    PremierEdge MICROSURGICAL KNIFE, 45 DEGREES STAB KNIFE, REF/Item Code: PE 3045, OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF: PE 3830; OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife, Item Code/ REF: PE 3128 , OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF: PE4828-TL; OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals Irrigation/Aspiration Set 21 Gauge, Dual Port; Item #1721-A - Disposable Bimanual Aspiration Handpiece 21g; Item #1721-I Disposable Bimanuals Irrigation/Aspiration Set, 21g, Open End; Item #1721-S Disposable Bimanuals Irrigation/Aspiration Set, 21g, Dual Port, Smooth. For use in cataract surgical procedures.

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code KYG·April 9, 2007

    PremierEdge MICROSURGICAL KNIFE, 2.5mm Clear Cornea Knife, REF/Item Code: PE 3125, OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    PremierEdge MICROSURGICAL KNIFE, 2.65mm Slit Knife, Item Code/REF: PE 3826; OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007