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Respironics California, LLC

FDA Regulatory Profile

Summary

Total Recalls
53 (11 Class I)
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0909-2022Class IPhilips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outsFebruary 28, 2022
Z-0908-2022Class IPhilips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)February 28, 2022
Z-0907-2022Class IPhilips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 10536February 28, 2022
Z-0663-2022Class IPhilips Respironics V60 Plus Ventilator Part Number 1138747January 24, 2022
Z-0662-2022Class IPhilips Respironics V60 Ventilator Part Number 1053617January 24, 2022
Z-2073-2021Class IPhilips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 June 18, 2021
Z-2074-2021Class IPhilips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60June 18, 2021
Z-1137-2021Class IIPHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: ThJanuary 6, 2021
Z-0914-2021Class IIPhilips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only witNovember 2, 2020
Z-0911-2021Class IIPhilips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only witNovember 2, 2020
Z-0906-2021Class IIPhilips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only witNovember 2, 2020
Z-0902-2021Class IIPhilips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only witNovember 2, 2020
Z-0910-2021Class IIPhilips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only wiNovember 2, 2020
Z-0917-2021Class IIPhilips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only witNovember 2, 2020
Z-0915-2021Class IIPhilips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used onlNovember 2, 2020
Z-0912-2021Class IIPhilips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only witNovember 2, 2020
Z-0908-2021Class IIPhilips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only witNovember 2, 2020
Z-0913-2021Class IIPhilips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used onlNovember 2, 2020
Z-0904-2021Class IIPhilips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only witNovember 2, 2020
Z-0916-2021Class IIPhilips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only wNovember 2, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K110083V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODEJanuary 13, 2012
K110795V200 INTELLI-TRAK OPTIONAugust 19, 2011
K102054V200 VENTILATORDecember 22, 2010
K082660V60 VENTILATOR, MODEL V8000January 9, 2009
K072450ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000December 12, 2007
K071212ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000July 30, 2007
K051262ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000July 8, 2005
K041412ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000June 18, 2004
K034032PLV CONTINUUM VENTILATOR, MODEL P2000March 16, 2004
K022750PLV CONTINUUM VENTILATOR, MODEL P1000November 20, 2003
K023350ESPRIT VENTILATOR WITH RESPIRATORY MECHANICSNovember 6, 2002