Respironics California, Inc.
Respironics California, Inc. holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2012, with 7 FDA device recalls on record.
Top product codes for Respironics California, Inc.
FDA recalls by Respironics California, Inc.
- Z-2061-2017 — Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
- Z-1687-2017 — Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709
- Z-0485-2015 — Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.
- Z-0008-2015 — Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
- Z-1537-2013 — 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.
- Z-2260-2012 — V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: 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 Ibs) 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.
- Z-2084-2013 — Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Respironics California, Inc.
- K110083 — V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
- K110795 — V200 INTELLI-TRAK OPTION
- K102054 — V200 VENTILATOR
- K082660 — V60 VENTILATOR, MODEL V8000
- K072450 — ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
- K071212 — ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000
- K051262 — ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
- K041412 — ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
- K034032 — PLV CONTINUUM VENTILATOR, MODEL P2000
- K022750 — PLV CONTINUUM VENTILATOR, MODEL P1000
- K023350 — ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
Data sourced from openFDA. This site is unofficial and independent of the FDA.