Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PhilipsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Respironics California with 53 device recalls and 11 510(k) clearances. The most recent is a device recall dated Apr 24, 2017: Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 105361….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 24, 2017 | Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Class I · Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acq | Device recalls |
| Feb 1, 2017 | Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLClass II · The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this c | Device recalls |
| Oct 29, 2014 | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-Class II · If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply pri | Device recalls |
| Sep 17, 2014 | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-contClass I · A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC pow | Device recalls |
| Jun 4, 2013 | Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 105361Class I · Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V | Device recalls |
| Jul 31, 2012 | V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended Class I · Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet | Device recalls |
| Jan 13, 2012 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODEK110083 · CBK | 510(k) clearances |
| Aug 19, 2011 | V200 INTELLI-TRAK OPTIONK110795 · CBK | 510(k) clearances |
| Dec 22, 2010 | V200 VENTILATORK102054 · CBK | 510(k) clearances |
| Jan 9, 2009 | V60 VENTILATOR, MODEL V8000K082660 · MNT | 510(k) clearances |
| Dec 12, 2007 | ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000K072450 · CBK | 510(k) clearances |
| Oct 29, 2007 | Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000Class II · The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display | Device recalls |
| Jul 30, 2007 | ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000K071212 · CBK | 510(k) clearances |
| Jul 8, 2005 | ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000K051262 · CBK | 510(k) clearances |
| Jun 18, 2004 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000K041412 · CBK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
