39 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code FMZ·June 30, 2021
Giraffe OmniBed, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand.
FDA Recall
Terminated
·Datex Ohmeda, Inc. dba GE Healthcare·Product code FMZ·June 20, 2008
Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
FDA Recall
Terminated
·Ohmeda Medical, A Div of Datex-Ohmeda Inc·Product code FMZ·October 17, 2003
Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code FMZ·January 31, 2008
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·May 1, 2012
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
FDA Recall
Terminated
·Ohmeda Medical·Product code FMZ·October 5, 2018
Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
FDA Recall
Terminated
·Ohmeda Medical·Product code FMZ·November 18, 2016
Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·January 8, 2013
Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed temperature controlled environment
FDA Recall
Terminated
·Ohmeda Medical·Product code FMZ·November 18, 2016
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·September 25, 2018
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·April 28, 2020
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·September 25, 2018
Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: A warmer for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators
FDA Recall
Terminated
·Ohmeda Medical, A division of Datex-Ohmeda, Inc.·Product code FMZ·April 25, 2005
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
FDA Recall
Terminated
·Natus Medical Incorporated·Product code FMZ·January 8, 2016
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·April 28, 2020
The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
FDA Recall
Terminated
·Natus Medical Incorporated·Product code FMZ·August 25, 2016
Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code FMZ·January 31, 2008
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·April 2, 2020