199 results
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89ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERRAD 200 STERILIZATION SYSTEM
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 9, 2010
INNOVA 2000
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code MQB·March 7, 2005
SIGNA ADVANATAGE 1.50 TELSA SX PLATFORM
FDA Adverse Event
Other
·GENERAL ELECTRIC COMPANY·Product code LNH·August 22, 1996
SIGNA ARTIST
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code LNK·April 22, 2021
GE 3.0T HDXT 23.0 MRI
FDA Adverse Event
Injury
·GENERAL ELECTRIC COMPANY·Product code LNH·July 10, 2020
MPX GENERATOR
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code IZO·October 22, 1996
MPX GENERATOR
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code IZO·October 22, 1996
NOT APPLICABLE
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code LNH·November 25, 2020
INFUSABLE
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code KZD·April 20, 2011
LUA 5000
FDA Adverse Event
Injury
·GENERAL ELECTRIC COMPANY·July 15, 1992
GE
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code DQK·August 9, 2005
GENERAL ELECTRIC AMX II
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code OXO·July 23, 2013
SIGNA ARTIST
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code LNK·February 9, 2021
DISCOVERY MR 750 3.0T
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY·Product code LNH·January 25, 2022
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 2, 2013
GE CIC PRO CLINICAL INFORMATION CENTER
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY -GE-·Product code DRT·June 7, 2010
AESTIVA
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC COMPANY/ DATEX-OHMEDA·Product code BSZ·July 2, 2007
COROMETRICS MONITOR
FDA Adverse Event
Death
·WIPRO GE HEALTHCARE PRIVATE LTD·Product code HGM·September 18, 2013
GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
FDA Recall
Terminated
·Datex Ohmeda, Inc·Product code BSZ·August 10, 2006
GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.
FDA Recall
Terminated
·Datex Ohmeda, Inc·Product code CBK·February 2, 2007