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Sources: EU EUDAMED, US FDA
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FDA Recall
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Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
FDA Recall
Terminated
·Ohmeda Medical, A division of Datex-Ohmeda, Inc.·Product code 80FMZ·June 13, 2003
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
Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MSX·May 8, 2009
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
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client)) The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity NetworkTM. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS). The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is for use by qualified personnel only.
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code MSX·June 25, 2010
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code CCK·June 11, 2014
Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614
FDA Recall
Terminated
·Kentec Medical Inc·Product code DQA·May 18, 2007
Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
FDA Recall
Terminated
·Datex-Ohmeda·Product code DQA·September 16, 2002
GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda Aisys Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
FDA Recall
Terminated
·Datex - Ohmeda, Inc·Product code BSZ·August 28, 2008
Datex-Ohmeda S/5 Aespire Anesthesia System 7100
FDA Recall
Terminated
·Datex-Ohmeda Inc·Product code BSZ·September 27, 2005
Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes.
FDA Recall
Terminated
·GE Healthcare·Product code BSZ·October 30, 2008
Datex-Ohmeda S/5 Aespire Anesthesia System 7900
FDA Recall
Terminated
·Datex-Ohmeda Inc·Product code BSZ·September 27, 2005
GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05, Datex-Ohmeda Inc., PO Box 7550 Madison, WI 53707-7550, USA, GE Healthcare Finland Oy, Helsinki, Finland PO Box 900. FI-00031 GE. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only.
FDA Recall
Terminated
·GE Healthcare·Product code MSX·January 26, 2009
GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code CBK·December 15, 2015
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KOI·April 9, 2014
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code CCL·May 23, 2014
GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code BSZ·December 15, 2015
Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital
FDA Recall
Terminated
·Ohmeda Medical·Product code LBI·November 18, 2016
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 Recall
Terminated
·GE Healthcare, LLC·Product code BTL·June 26, 2012
Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
FDA Recall
Terminated
·Ohmeda Medical·Product code FOX·December 1, 2017