7 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.
FDA Recall
Terminated
·Respironics, Inc.·Product code CBK·October 11, 2011
FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
FDA Recall
Terminated
·Respironics Novametrix, LLC.·Product code BZK·July 29, 2011
Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
FDA Recall
Terminated
·Respironics, Inc.·Product code CBK·June 10, 2010
PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.
FDA Recall
Terminated
·Respironics Novametrix, LLC.·Product code BZK·July 29, 2011
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.
FDA Recall
Terminated
·Respironics, Inc.·Product code CBK·April 27, 2012
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
FDA Recall
Terminated
·Phillips Respironics, Inc.·Product code CBK·February 11, 2014
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014