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Respironics California, Inc.

Last updated May 27, 2026

What Respironics California, Inc. makes

Respironics California, Inc. manufactures portable electric ventilators and reusable nasal masks for CPAP/BPAP therapy, designed for continuous positive airway pressure and bilevel positive airway pressure treatment.

Their devices are classified as Class II under FDA regulations and are authorised via 510(k) clearances and the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Respironics California, Inc. manufacture?

Respironics California, Inc. specializes in respiratory therapy devices, specifically portable electric ventilators and reusable nasal masks for CPAP (continuous positive airway pressure) and BPAP (bilevel positive airway pressure) therapy. These devices are designed to support patients requiring airway pressure treatment, helping maintain open airways during sleep or other medical conditions.

Where is Respironics California, Inc. based?

The company is headquartered in the United States. This location reflects its focus on serving the North American market, though its devices may also be used globally depending on local regulatory requirements.

Which regulatory registries or databases list Respironics California, Inc.’s devices?

Respironics California, Inc.’s devices are authorised through the FDA’s 510(k) clearance process and are tracked via the FDA’s Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. medical device regulations and provide transparency on device authorisation status.

How are Respironics California, Inc.’s devices classified under FDA regulations?

The company’s devices fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure safety and effectiveness. Class II devices require pre-market clearance via the 510(k) pathway.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: philips.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(724)744-2500
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 079550876

Catalogue (44)

Device	Model / Reference	Registries	Class	Status
Philips	1055579	FDA UDI	Class II	Active
Philips Respironics	V60	FDA UDI	Class II	Active
Philips	1080782	FDA UDI	Class II	Active
Philips	1109866	FDA UDI	Class II	Active
Philips	1055588	FDA UDI	Class II	Active
Philips	1055568	FDA UDI	Class II	Active
Philips	1055575	FDA UDI	Class II	Active
Philips	1055584	FDA UDI	Class II	Active
Philips	1076716	FDA UDI	Class II	Active
Philips	1076374	FDA UDI	Class II	Active
Philips	1053614	FDA UDI	Class II	Active
Philips	1076709	FDA UDI	Class II	Active
Philips	1113371	FDA UDI	Class II	Active
Philips	1109869	FDA UDI	Class II	Active
DreamWear Full	00	FDA UDI	Class II	Active
Philips	1055569	FDA UDI	Class II	Active
Philips	1055585	FDA UDI	Class II	Active
Philips	1053615	FDA UDI	Class II	Active
Philips Respironics	V60	FDA UDI	Class II	Active
Philips	1055587	FDA UDI	Class II	Active
Philips	1109865	FDA UDI	Class II	Active
Philips	1109602	FDA UDI	Class II	Active
Philips	1055576	FDA UDI	Class II	Active
Philips	1053613	FDA UDI	Class II	Active
Philips	1055578	FDA UDI	Class II	Active
Philips Respironics	V60	FDA UDI	Class II	Active
Philips	1055586	FDA UDI	Class II	Active
Philips	1055580	FDA UDI	Class II	Active
Philips	1109881	FDA UDI	Class II	Active
Philips	1113392	FDA UDI	Class II	Active
Philips	1080588	FDA UDI	Class II	Active
Philips	1055581	FDA UDI	Class II	Active
Philips	1055571	FDA UDI	Class II	Active
Plv Continuum Ventilator, Model P2000	K034032	FDA 510(k)	Class II	Active
Esprit Ventilator Speaking Mode Option, Model V1000	K071212	FDA 510(k)	Class II	Active
V200 Intelli-Trak Option	K110795	FDA 510(k)	Class II	Active
Plv Continuum Ventilator, Model P1000	K022750	FDA 510(k)	Class II	Active
Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000	K072450	FDA 510(k)	Class II	Active
Esprit Ventilator With Respiratory Mechanics	K023350	FDA 510(k)	Class II	Active
V200 Ventilator With Aprv Mode, Esprit Ventilator With Aprv Mode	K110083	FDA 510(k)	Class II	Active
V200 Ventilator	K102054	FDA 510(k)	Class II	Active
Esprit Ventilator Neonatal Option, Model V1000	K051262	FDA 510(k)	Class II	Active
Esprit Ventilator With Nico-Esprit Interface Option, Model V1000	K041412	FDA 510(k)	Class II	Active
V60 Ventilator, Model V8000	K082660	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (67)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Respironics California, Inc. has 67 recall records initiated between June 1, 2001, and February 28, 2022, with statuses recorded as open, classified, or terminated. The recalls involve ventilators and related components, citing issues such as spontaneous suspension of ventilatory support due to hardware/software incompatibility, drift in flow sensors, battery failures (overdischarge or prolonged storage), connector pin displacement causing data transmission issues, power supply malfunctions, thermal damage to components, premature valve failure, valve sticking, unresponsive touchscreens, and power supply snubber board failures in certain voltage ranges.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 28, 2022	Z-0907-2022	—	open, classified	Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Feb 28, 2022	Z-0909-2022	—	open, classified	Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Feb 28, 2022	Z-0908-2022	—	open, classified	Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Jan 24, 2022	Z-0663-2022	—	open, classified	A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Jan 24, 2022	Z-0662-2022	—	open, classified	A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Jun 18, 2021	Z-2074-2021	—	open, classified	It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.
Jun 18, 2021	Z-2073-2021	—	open, classified	It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.
Jan 6, 2021	Z-1137-2021	—	open, classified	Due to unqualified "design verification" batteries being shipped to customers.
Nov 2, 2020	Z-0908-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0915-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0905-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0911-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0912-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0902-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0916-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0917-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0907-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0910-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0913-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0914-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0903-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0904-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0906-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Nov 2, 2020	Z-0909-2021	—	open, classified	Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Oct 30, 2020	Z-0894-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0889-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0895-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0898-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0900-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0885-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0901-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0893-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0887-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0888-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0896-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0899-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0886-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0897-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0890-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0891-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Oct 30, 2020	Z-0892-2021	—	terminated	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Mar 5, 2020	Z-1622-2020	—	open, classified	Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia
Sep 11, 2019	Z-1155-2020	—	open, classified	Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
Sep 11, 2019	Z-1154-2020	—	open, classified	Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
Sep 11, 2019	Z-1152-2020	—	open, classified	Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
Sep 11, 2019	Z-1153-2020	—	open, classified	Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
Apr 24, 2017	Z-2061-2017	—	terminated	Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.
Feb 1, 2017	Z-1687-2017	—	terminated	The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease.
Oct 29, 2014	Z-0485-2015	—	terminated	If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.
Sep 17, 2014	Z-0008-2015	—	terminated	A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
Jun 4, 2013	Z-1537-2013	—	terminated	Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.
Jul 31, 2012	Z-2260-2012	—	terminated	Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio
Jul 2, 2010	Z-0457-2011	—	terminated	Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage.
Oct 26, 2009	Z-0176-2010	—	terminated	The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can result in power loss during ventilation fo
Apr 22, 2009	Z-1813-2009	—	terminated	The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in this condition results in overcharging and
Sep 22, 2008	Z-1606-2009	—	terminated	Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cau
Jan 25, 2008	Z-2004-2008	—	terminated	This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported a burning smell coming from the ventilator.
Jan 25, 2008	Z-2002-2008	—	terminated	This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported a burning smell coming from the ventilator.
Jan 25, 2008	Z-2003-2008	—	terminated	This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported a burning smell coming from the ventilator.
Oct 29, 2007	Z-2084-2013	—	terminated	The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.
Aug 8, 2006	Z-0047-2007	—	terminated	This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases in which a fan also failed, have shown signs of fire damage.
Mar 20, 2006	Z-0808-06	—	terminated	Flow valve failures- When failure occurs, air flow from the ventilator ceases resulting in the PLVC I transitioning into a 'Vent Inop' mode whereby the safety valve is activated, opening the circuit to ambient air. Ventilator dependent patients may not receive adequate ventilatory support if this problem occurs.
Nov 18, 2005	Z-0354-06	—	terminated	During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.
Jul 14, 2003	Z-0722-04	—	terminated	Valves may stick in the closed position due to manufacturing error.
Feb 20, 2002	Z-1230-04	—	terminated	Flow sensors would exhibit drift.
Jun 8, 2001	Z-0951-03	—	terminated	Material hardness on original design check valve may cause premature failure.
Jun 1, 2001	Z-0903-04	—	terminated	Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.