Respironics California, LLC
FDA Regulatory Profile
Respironics California, LLC appears in FDA public data with 53 recalls — including 11 Class I (most serious) —, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0907-2022, Class I) was initiated on February 28, 2022. Its most recent 510(k) clearance was granted on January 13, 2012.
Summary
- Total Recalls
- 53 (11 Class I)
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0907-2022 | Class I | Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 10536 | February 28, 2022 |
| Z-0908-2022 | Class I | Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276) | February 28, 2022 |
| Z-0909-2022 | Class I | Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outs | February 28, 2022 |
| Z-0663-2022 | Class I | Philips Respironics V60 Plus Ventilator Part Number 1138747 | January 24, 2022 |
| Z-0662-2022 | Class I | Philips Respironics V60 Ventilator Part Number 1053617 | January 24, 2022 |
| Z-2073-2021 | Class I | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 | June 18, 2021 |
| Z-2074-2021 | Class I | Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60 | June 18, 2021 |
| Z-1137-2021 | Class II | PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: Th | January 6, 2021 |
| Z-0903-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only wit | November 2, 2020 |
| Z-0912-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only wit | November 2, 2020 |
| Z-0914-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only wit | November 2, 2020 |
| Z-0910-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only wi | November 2, 2020 |
| Z-0916-2021 | Class II | Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only w | November 2, 2020 |
| Z-0902-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only wit | November 2, 2020 |
| Z-0904-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only wit | November 2, 2020 |
| Z-0909-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only wi | November 2, 2020 |
| Z-0911-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only wit | November 2, 2020 |
| Z-0915-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used onl | November 2, 2020 |
| Z-0907-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only wit | November 2, 2020 |
| Z-0905-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only wit | November 2, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE | January 13, 2012 |
| K110795 | V200 INTELLI-TRAK OPTION | August 19, 2011 |
| K102054 | V200 VENTILATOR | December 22, 2010 |
| K082660 | V60 VENTILATOR, MODEL V8000 | January 9, 2009 |
| K072450 | ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 | December 12, 2007 |
| K071212 | ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 | July 30, 2007 |
| K051262 | ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 | July 8, 2005 |
| K041412 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 | June 18, 2004 |
| K034032 | PLV CONTINUUM VENTILATOR, MODEL P2000 | March 16, 2004 |
| K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 | November 20, 2003 |
| K023350 | ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS | November 6, 2002 |