97 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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
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
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020