BEUDAMED
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    Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

    FDA Recall
    Open, Classified ·Product code OWQ·December 22, 2025

    GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·October 17, 2011

    Advantx-E is an angiographic X-Ray system.

    FDA Recall
    Terminated ·GE Healthcare·Product code IZI·January 14, 2008

    Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·January 14, 2008

    Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH

    FDA Recall
    Open, Classified ·Product code OWQ·December 22, 2025

    Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·January 14, 2008

    Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·January 14, 2008

    Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·January 14, 2008

    GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL). The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·September 22, 2011

    GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS system generates digital mammographic images, which can be used for screening and diagnosis of breast cancer. The Senographe DS is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·September 22, 2011

    Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane system with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·January 14, 2008

    The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BSF·February 9, 2011

    Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

    FDA Recall
    Terminated ·Solta Medical, Inc.·Product code ONG·December 15, 2010

    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

    FDA Recall
    Terminated ·Solta Medical, Inc.·Product code ONG·March 20, 2014