58 results
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28ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
FDA Recall
Terminated
·Microbiologics Inc·Product code PMN·January 31, 2019
Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.
FDA Recall
Terminated
·Respironics California Inc·Product code MNS·September 22, 2008
Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
FDA Recall
Terminated
·Maquet Inc.·Product code CBK·December 22, 2011
Servo-s ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
FDA Recall
Terminated
·Maquet Inc.·Product code CBK·December 22, 2011
Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
FDA Recall
Terminated
·Respironics California Inc·Product code CBK·June 1, 2001
Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.
FDA Recall
Terminated
·Vapotherm, Inc.·Product code BTT·October 13, 2005
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
FDA Recall
Terminated
·ArjoHuntleigh Inc.·Product code IKZ·September 11, 2013
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).
FDA Recall
Terminated
·Ventlab LLC·Product code CCK·March 15, 2016
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BTT·December 20, 2005
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BTT·December 20, 2005
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT110
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BTT·December 20, 2005
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BTT·December 20, 2005
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012