GE Healthcare, LLC - Giraffe OmniBed Carestation - Class 2 Recall
Giraffe OmniBed Carestation CS1 - Product Usage: 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 5, 2019 Category: Medical Devices Source Type: alerts

Ohmeda Medical - Giraffe Omnibed - Class 2 Recall
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...
Source: Medical Device Recalls - October 5, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Panda Infant Radiant Warmer - Class 1 Recall
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 12, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Giraffe Warmer - Class 1 Recall
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 12, 2019 Category: Medical Devices Source Type: alerts

Avid Medical, Inc. - AVID TruCustom - Class 2 Recall
AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 1, 2018 Category: Medical Devices Source Type: alerts

Ohmeda Medical - Ohmeda Medical Omnibed - Class 2 Recall
Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). 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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Ohmeda Medical - Giraffe Incubator - Class 2 Recall
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%). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Ohmeda Medical - Infant Warmer System - Class 2 Recall
IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes: 1. Manual: The clinician sets the appropriate he...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Ohmeda Medical - Giraffe Bedded Warmer, Panda Warmer - Class 2 Recall
Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provi...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Ohmeda Medical - Giraffe OmniBed - Class 2 Recall
Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- 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, temperatures controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neon...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Ohmeda Medical - Modification to Giraffe and Panda Warmers - Class 2 Recall
Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may ...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Ohmeda Medical - Giraffe Incubator - Class 2 Recall
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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Ohmeda Medical - Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply - Class 2 Recall
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 senso...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Philips Electronics North America Corporation - Class 2 Recall
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2017 Category: Medical Equipment Source Type: alerts

Philips Electronics North America Corporation - Philips Allura Xper FD10 - Class 2 Recall
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2017 Category: Medical Equipment Source Type: alerts

Philips Electronics North America Corporation - Philips Allura Xper FD20 - Class 2 Recall
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Symbia T Series is a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. T...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Intevo Series system is a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and canc...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Symbia S Series system is a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disord...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts

Otto Bock Healthcare GmbH - Ottobock Pheon 3R62 Knee Joint - Class 2 Recall
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 25, 2015 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Symbia T Series - Class 2 Recall
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), usin...
Source: Medical Device Recalls - January 7, 2015 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Symbia S Series - Class 2 Recall
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), usin...
Source: Medical Device Recalls - January 7, 2015 Category: Medical Equipment Source Type: alerts

GE Healthcare - Panda iRes Infant Warmers integrated with Nellcor SpO2 - Class 2 Recall
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare - Panda WallMount Infant Warmers, integrated with Nellcor SpO2 - Class 2 Recall
Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare - Giraffe Infant Warmers integrated with Nellcor SpO2 - Class 2 Recall
Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare - Nellcor SpO2 Upgrade kit - Class 2 Recall
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare - Panda Freestanding Infant Warmers, integrated with Nellcor SpO2 - Class 2 Recall
Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Emergency Powered Ventilator Resusicitator - Class 1 Recall
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate s transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare - Panda iRes Infant Warmers - Class 2 Recall
Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare - Giraffe Infant Warmers - Class 2 Recall
Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2014 Category: Medical Equipment Source Type: alerts