2,945 results
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125ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·PHILIPS / RESPIRONICS, INC.·Product code BZD·February 15, 2022
AUTO BIPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 9, 2023
PHILIPS / RESPIRONICS, INC.
FDA Adverse Event
Injury
·PHILIPS / RESPIRONICS, INC.·Product code BZD·August 19, 2021
DREAMSTATION 1
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 5, 2022
THE DREAMSTATION AUTOBIPAP MACHINE
FDA Adverse Event
Malfunction
·PHILIPS / RESPIRONICS, INC.·Product code BZD·October 1, 2021
ALAIR?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code OOY·April 17, 2015
PHILIPS RESPIRONICS REMSTAR
FDA Adverse Event
Injury
·PHILIPS / RESPIRONICS, INC.·Product code BZD·December 5, 2022
PHILIPS RESPIRONICS DREAMWEAR, UNDER THE NOSE MASK
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·December 22, 2022
COMFORTGEL FULL FACEMASK WITH HEADGEAR
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·July 7, 2010
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code BZD·June 14, 2022
RESPIRONICS INC/PHILIPS
FDA Adverse Event
Injury
·RESPIRONICS·Product code MNT·April 28, 2015
REMSTAR AUTO A-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 14, 2022
EVERFLO
FDA Adverse Event
Malfunction
·PHILIPS-RESPIRONICS·Product code CAW·August 11, 2023
EVERFLO
FDA Adverse Event
Injury
·PHILIPS-RESPIRONICS·Product code CAW·August 11, 2023
EVERFLO
FDA Adverse Event
Death
·PHILIPS-RESPIRONICS·Product code CAW·August 11, 2023
EVERFLO
FDA Adverse Event
Injury
·PHILIPS-RESPIRONICS·Product code CAW·August 11, 2023
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code BZD·June 28, 2022
SMARTMONITOR 2 WITH MODEM
FDA Adverse Event
Death
·CIRCADIANCE LLC·Product code FLS·September 30, 2015
EVERFLO
FDA Adverse Event
Injury
·PHILIPS-RESPIRONICS·Product code CAW·August 11, 2023
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
FDA Recall
Terminated
·Respironics California Inc·Product code MNT·June 4, 2013