7 results
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29ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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Philips Respironics V60 Ventilator Part Number 1053617
FDA Enforcement
Class I
·Ongoing·Respironics California, LLC·March 9, 2022
Philips Respironics V60 Plus Ventilator Part Number 1138747
FDA Enforcement
Class I
·Ongoing·Respironics California, LLC·March 9, 2022
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
FDA Enforcement
Class I
·Ongoing·Respironics California, LLC·April 27, 2022
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
FDA Enforcement
Class I
·Ongoing·Respironics California, LLC·April 27, 2022
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
FDA Enforcement
Class I
·Ongoing·Respironics California, LLC·April 27, 2022
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus 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, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
FDA Enforcement
Class I
·Ongoing·Respironics California, LLC·July 28, 2021
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus 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, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
FDA Enforcement
Class I
·Ongoing·Respironics California, LLC·July 28, 2021